Description: The Company: This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. The company has 80 employees and has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. The management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and the development of manufacturing processes utilizing good manufacturing practices (GMPs). The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how and expertise to the development of CTI-1601 and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position Summary: The Associate Director/Director, Quality, Validation and Data Integrity will be responsible to provide quality support and oversight for Larimar's GxP Computer Systems and to manage Larimar's Data Integrity program, ensuring compliance with relevant regulatory requirements and industry standards/best practices. This position reports to the Senior Director, Quality. This role will require being in the office located in Bala Cynwyd, PA. At the current time, the number of days in the office is flexible and may change over time. Job Responsibilities: The responsibilities for the Associate Director/Director, Quality, Validation and Data Integrity may include, but are not limited to the following activities: Provide Quality oversight of Computer System Validation (CSV)/Computer Software Assurance (CSA) activities related to initial implementations, changes, periodic review, maintenance, and decommissioning of GxP systems. Execute and manage risk assessment, planning, and execution/mitigation activities to ensure computerized systems used to support GxP operations are maintained in a qualified state throughout their lifecycles. Review and approve relevant validation documentation, including but not limited to: URS, FRS, CS, DS, IOQ, PQ/UAT, VP, VSR, RA, TM. Streamline and improve processes for GxP systems compliance in collaboration with IT and the business. Participate in project teams to provide guidance and approval of project Validation documentation and relevant Change Controls. Manage the data integrity program, including the timeline of activities for data integrity deliverables (e.g., data integrity assessments, CAPA actions, remediations etc.). Deliver training on validation and data integrity principles/requirements to foster employee awareness and accountability. Create and/or review and approve Policies, SOPs and Work Instructions supporting validation and data integrity activities. Participate in vendor audits/assessments and qualification activities or internal audits involving GxP computerized systems as a Subject Matter Expert (SME). Support GxP health authority inspections by serving as SME for computerized system and data integrity topics. Support other Quality activities, as required. Requirements: Qualifications: Title and compensation will be dependent on years of experience and qualifications. This role requires a Bachelor's degree in a scientific or technical discipline and 8+ years of experience in a Quality role in the biotechnology/pharmaceutical industry with at least 3 years' direct experience with GxP computer systems validation. Experience with GxP validation methodology is required. Strong understanding of 21 CFR Part 11, EU Annex 11 regulations, GAMP 5 concepts, applications and best practices is required. Must possess strong attention to detail while having the ability to work independently and collaboratively in a fast-paced environment. Demonstrated ability to initiate process improvements, set priorities and meet aggressive timelines is required. Benefits: Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. Equal Opportunity Employment We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the employment relationship with all employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI646fe2afcaa7-0848
07/24/2026
Full time
Description: The Company: This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. The company has 80 employees and has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. The management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and the development of manufacturing processes utilizing good manufacturing practices (GMPs). The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how and expertise to the development of CTI-1601 and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position Summary: The Associate Director/Director, Quality, Validation and Data Integrity will be responsible to provide quality support and oversight for Larimar's GxP Computer Systems and to manage Larimar's Data Integrity program, ensuring compliance with relevant regulatory requirements and industry standards/best practices. This position reports to the Senior Director, Quality. This role will require being in the office located in Bala Cynwyd, PA. At the current time, the number of days in the office is flexible and may change over time. Job Responsibilities: The responsibilities for the Associate Director/Director, Quality, Validation and Data Integrity may include, but are not limited to the following activities: Provide Quality oversight of Computer System Validation (CSV)/Computer Software Assurance (CSA) activities related to initial implementations, changes, periodic review, maintenance, and decommissioning of GxP systems. Execute and manage risk assessment, planning, and execution/mitigation activities to ensure computerized systems used to support GxP operations are maintained in a qualified state throughout their lifecycles. Review and approve relevant validation documentation, including but not limited to: URS, FRS, CS, DS, IOQ, PQ/UAT, VP, VSR, RA, TM. Streamline and improve processes for GxP systems compliance in collaboration with IT and the business. Participate in project teams to provide guidance and approval of project Validation documentation and relevant Change Controls. Manage the data integrity program, including the timeline of activities for data integrity deliverables (e.g., data integrity assessments, CAPA actions, remediations etc.). Deliver training on validation and data integrity principles/requirements to foster employee awareness and accountability. Create and/or review and approve Policies, SOPs and Work Instructions supporting validation and data integrity activities. Participate in vendor audits/assessments and qualification activities or internal audits involving GxP computerized systems as a Subject Matter Expert (SME). Support GxP health authority inspections by serving as SME for computerized system and data integrity topics. Support other Quality activities, as required. Requirements: Qualifications: Title and compensation will be dependent on years of experience and qualifications. This role requires a Bachelor's degree in a scientific or technical discipline and 8+ years of experience in a Quality role in the biotechnology/pharmaceutical industry with at least 3 years' direct experience with GxP computer systems validation. Experience with GxP validation methodology is required. Strong understanding of 21 CFR Part 11, EU Annex 11 regulations, GAMP 5 concepts, applications and best practices is required. Must possess strong attention to detail while having the ability to work independently and collaboratively in a fast-paced environment. Demonstrated ability to initiate process improvements, set priorities and meet aggressive timelines is required. Benefits: Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. Equal Opportunity Employment We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the employment relationship with all employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI646fe2afcaa7-0848
Position Summary The position is responsible for implementing the day-to-day activities of the American Chemistry Council's (ACC) political grassroots program, including state legislative and regulatory tracking of various issues impacting member companies. The position is also responsible for monitoring state legislative and regulatory agency activities, developing advocacy materials for grassroots and lobbying efforts, interacting with contract lobbyists and consultants as well as representing the ACC before legislative and regulatory negotiations. The position requires routine travel throughout the Southeastern region. The position reports directly to the Senior Director, Southern Region. Major Duties and Responsibilities Maintains and improves the current advocacy tracking website as well as identifies potential tools to enhance overall online state advocacy efforts. Manages the day-to-day operations of the grassroots program, including websites, in coordination with State and Federal Affairs staff.Coordinates and works with ACC's communications staff to develop and prepare various materials for members and external audiences.Communicates frequently with the State Affairs staff, ACC issue managers and teams to ensure the accuracy of information on legislative tracking platforms. Identifies and writes articles/stories on state legislative, regulatory and/or political news as well as copy writes and edits newsletter content, as necessary. Monitors the activities of public policy groups, industry trade associations and other advocacy groups for purposes of ensuring ACC's ability to defend issues/positions or participation in meetings.Develops and maintains strong working relationships with ACC staff, member company representatives, and various consultants/vendors.Engages in direct advocacy activities, including lobbying state-wide officials, legislators and regulators.Works with allied trade groups and other relevant stakeholders in developing coalitions to support advocacy efforts. Ensures all lobbying and campaign filings, registrations and related expenses are in full compliance with state and/or local laws.Performs other related duties as assigned. Qualifications/Requirements Required Bachelor's degree political science, public relations, communications, marketing or related field.Three years' relevant experience.Familiarity with legislative and regulatory processes on a state level.Experience in campaign, grassroots organizing, official governmental work, or lobbying. Ability to prioritize and manage multiple issues, projects, tasks, and information/requests.Strong written and verbal communication skills.Experience working with internet applications, including website management.Working knowledge of Microsoft Office including Outlook, Word, Excel, PowerPoint and Access.Ability to travel, as needed, within the United States. Preferred State government relations, legislative, communications and/or monitoring experience.Public speaking experience.Corporate or trade association experience and/or legislative staff experience. Experience working with databases and use of artificial intelligence tools. ACC offers medical, dental, vision as well as 401(k) matching contribution up to 6% and a 6% contribution to the Profit-Sharing Plan, both vested immediately at 100%. Additionally, employees have access to a no cost onsite fitness center and subsidized yoga classes as well as eligibility for performance-based merit increases and discretionary bonus program. PI2d5ba4ad5-
07/24/2026
Full time
Position Summary The position is responsible for implementing the day-to-day activities of the American Chemistry Council's (ACC) political grassroots program, including state legislative and regulatory tracking of various issues impacting member companies. The position is also responsible for monitoring state legislative and regulatory agency activities, developing advocacy materials for grassroots and lobbying efforts, interacting with contract lobbyists and consultants as well as representing the ACC before legislative and regulatory negotiations. The position requires routine travel throughout the Southeastern region. The position reports directly to the Senior Director, Southern Region. Major Duties and Responsibilities Maintains and improves the current advocacy tracking website as well as identifies potential tools to enhance overall online state advocacy efforts. Manages the day-to-day operations of the grassroots program, including websites, in coordination with State and Federal Affairs staff.Coordinates and works with ACC's communications staff to develop and prepare various materials for members and external audiences.Communicates frequently with the State Affairs staff, ACC issue managers and teams to ensure the accuracy of information on legislative tracking platforms. Identifies and writes articles/stories on state legislative, regulatory and/or political news as well as copy writes and edits newsletter content, as necessary. Monitors the activities of public policy groups, industry trade associations and other advocacy groups for purposes of ensuring ACC's ability to defend issues/positions or participation in meetings.Develops and maintains strong working relationships with ACC staff, member company representatives, and various consultants/vendors.Engages in direct advocacy activities, including lobbying state-wide officials, legislators and regulators.Works with allied trade groups and other relevant stakeholders in developing coalitions to support advocacy efforts. Ensures all lobbying and campaign filings, registrations and related expenses are in full compliance with state and/or local laws.Performs other related duties as assigned. Qualifications/Requirements Required Bachelor's degree political science, public relations, communications, marketing or related field.Three years' relevant experience.Familiarity with legislative and regulatory processes on a state level.Experience in campaign, grassroots organizing, official governmental work, or lobbying. Ability to prioritize and manage multiple issues, projects, tasks, and information/requests.Strong written and verbal communication skills.Experience working with internet applications, including website management.Working knowledge of Microsoft Office including Outlook, Word, Excel, PowerPoint and Access.Ability to travel, as needed, within the United States. Preferred State government relations, legislative, communications and/or monitoring experience.Public speaking experience.Corporate or trade association experience and/or legislative staff experience. Experience working with databases and use of artificial intelligence tools. ACC offers medical, dental, vision as well as 401(k) matching contribution up to 6% and a 6% contribution to the Profit-Sharing Plan, both vested immediately at 100%. Additionally, employees have access to a no cost onsite fitness center and subsidized yoga classes as well as eligibility for performance-based merit increases and discretionary bonus program. PI2d5ba4ad5-
Who We Are As the largest private-sector power producer in the world and the nation's largest producer of clean and reliable energy, Constellation is focused on our purpose: lighting the way to a brilliant tomorrow for all. We have been the leader in clean energy production for more than a decade, and we are cultivating a workplace where our employees can grow, thrive, and contribute. Now integrated with Calpine, our portfolio includes 55 gigawatts of capacity from nuclear, natural gas, geothermal, hydro, wind and solar facilities, with the generating capacity to power the equivalent of 27 million homes. Our culture and employee experience make it clear: We are powered by passion and purpose. Together, we're creating healthier communities and a cleaner planet, and our people are the driving force behind our success. At Constellation, you can build a fulfilling career with opportunities to learn, grow and make an impact. By doing our best work and meeting new challenges, we can accomplish great things. Join us in meeting the country's energy needs today and tomorrow. Total Rewards Constellation offers an extensive selection of benefits and rewards to help our employees thrive professionally and personally. We provide competitive compensation and a wide-range of benefits that support both employees and their families, helping them prepare for the future. In addition to highly competitive salaries, eligible employees are offered a bonus program, 401(k) with company match, employee stock purchase program comprehensive medical, dental and vision benefits, including robust wellbeing programs disability and life insurance benefits paid time off for vacation, holidays, and sick days and much more. Expected salary range of $152,100 to $169,000, varies based on experience, along with comprehensive benefits package that includes bonus and 401(k). Primary Purpose of Position Performs advanced regulatory/technical problem solving and provides analysis/insights in support of plant and fleet regulatory activities. Possesses superior knowledge in functional discipline and its practical application and has excellent knowledge of applicable industry codes and regulations. Understands interrelations and functions of various organizations (e.g., Nuclear Regulatory Commission (NRC), Institute of Nuclear Power Operators (INPO), Nuclear Energy Institute (NEI), North American Electric Reliability Corporation (NERC) etc.) related to nuclear power. Functions as a leader with recognized level of expertise in the regulatory area and is a subject matter expert. As a subject matter expert, leads industry trade groups and works with regulatory agencies to influence programs, projects and regulatory decisions. Develops relationships with key stakeholders and is recognized by peers and supervisors as an expert in his/her respective regulatory area. Trains, mentors and coaches' station and corporate regulatory personnel, and develops and provides training as appropriate. Primary Duties and Accountabilities Perform advanced regulatory and technical tasks and provide insights in support of plant and fleet regulatory activities. Provide initial or complete task management of regulatory issues. Assure all regulatory products prepared or overseen are in accordance with applicable procedures, licensing basis, industry codes, standards, and all regulatory requirements. Provide regulatory/technical expertise and leadership through direct involvement to resolve regulatory issues in assigned programs and other regulatory areas, as necessary. Perform independent and in-depth research, reviews, studies and analyses to develop, manage and implement regulatory activities, related to plant safety, reliability, maintainability, and availability ensuring compliance to site's needs, regulatory requirements, and corporate policies. Provide industry leadership and interface directly with regulatory decision-makers and support staff to influence and drive regulatory decisions and policies consistent with Constellation's goals Train and mentor corporate and station regulatory personnel and other functional areas in subject matter areas of expertise Provide strategic recommendation on technologies and techniques to improve performance, simplify operation, reduce costs, reduce regulatory burden, correct regulatory non-compliances, or comply with changes in codes or regulations. All other job assignments and/or duties pursuant to company policy or as directed by management to include but not limited to: (Emergency Response duties and/or coverage, Department duty coverage and/or call out, and positions outside of department in support of outage activities etc.). Minimum Qualifications Bachelor's degree in Engineering or equivalent technical degree Minimum of 10 years of professional relevant nuclear power or North America Electric Reliability Corporation (NERC) professional experience and exceptional performance Superior regulatory/technical expertise in a specific area (e.g., licensing actions, reportability, performance improvement, etc.) and recognized regulatory resource (internal/external) Strong written and oral communication skills Approval of VP Licensing & Regulatory Affairs required to obtain this classification (and recommendation of Sr. Manager Licensing /Director-Licensing/Regulatory Assurance Manager and Site Vice President, as applicable) Maintain minimum access requirement or unescorted access requirements, as applicable, and favorable medical examination and/or testing in accordance with position duties Preferred Qualifications Previous Senior Reactor Operator (SRO) license/certification Advanced technical degree or related coursework Highly seeking previous Nuclear, NRC, Regulatory or Licensing experience
07/19/2026
Full time
Who We Are As the largest private-sector power producer in the world and the nation's largest producer of clean and reliable energy, Constellation is focused on our purpose: lighting the way to a brilliant tomorrow for all. We have been the leader in clean energy production for more than a decade, and we are cultivating a workplace where our employees can grow, thrive, and contribute. Now integrated with Calpine, our portfolio includes 55 gigawatts of capacity from nuclear, natural gas, geothermal, hydro, wind and solar facilities, with the generating capacity to power the equivalent of 27 million homes. Our culture and employee experience make it clear: We are powered by passion and purpose. Together, we're creating healthier communities and a cleaner planet, and our people are the driving force behind our success. At Constellation, you can build a fulfilling career with opportunities to learn, grow and make an impact. By doing our best work and meeting new challenges, we can accomplish great things. Join us in meeting the country's energy needs today and tomorrow. Total Rewards Constellation offers an extensive selection of benefits and rewards to help our employees thrive professionally and personally. We provide competitive compensation and a wide-range of benefits that support both employees and their families, helping them prepare for the future. In addition to highly competitive salaries, eligible employees are offered a bonus program, 401(k) with company match, employee stock purchase program comprehensive medical, dental and vision benefits, including robust wellbeing programs disability and life insurance benefits paid time off for vacation, holidays, and sick days and much more. Expected salary range of $152,100 to $169,000, varies based on experience, along with comprehensive benefits package that includes bonus and 401(k). Primary Purpose of Position Performs advanced regulatory/technical problem solving and provides analysis/insights in support of plant and fleet regulatory activities. Possesses superior knowledge in functional discipline and its practical application and has excellent knowledge of applicable industry codes and regulations. Understands interrelations and functions of various organizations (e.g., Nuclear Regulatory Commission (NRC), Institute of Nuclear Power Operators (INPO), Nuclear Energy Institute (NEI), North American Electric Reliability Corporation (NERC) etc.) related to nuclear power. Functions as a leader with recognized level of expertise in the regulatory area and is a subject matter expert. As a subject matter expert, leads industry trade groups and works with regulatory agencies to influence programs, projects and regulatory decisions. Develops relationships with key stakeholders and is recognized by peers and supervisors as an expert in his/her respective regulatory area. Trains, mentors and coaches' station and corporate regulatory personnel, and develops and provides training as appropriate. Primary Duties and Accountabilities Perform advanced regulatory and technical tasks and provide insights in support of plant and fleet regulatory activities. Provide initial or complete task management of regulatory issues. Assure all regulatory products prepared or overseen are in accordance with applicable procedures, licensing basis, industry codes, standards, and all regulatory requirements. Provide regulatory/technical expertise and leadership through direct involvement to resolve regulatory issues in assigned programs and other regulatory areas, as necessary. Perform independent and in-depth research, reviews, studies and analyses to develop, manage and implement regulatory activities, related to plant safety, reliability, maintainability, and availability ensuring compliance to site's needs, regulatory requirements, and corporate policies. Provide industry leadership and interface directly with regulatory decision-makers and support staff to influence and drive regulatory decisions and policies consistent with Constellation's goals Train and mentor corporate and station regulatory personnel and other functional areas in subject matter areas of expertise Provide strategic recommendation on technologies and techniques to improve performance, simplify operation, reduce costs, reduce regulatory burden, correct regulatory non-compliances, or comply with changes in codes or regulations. All other job assignments and/or duties pursuant to company policy or as directed by management to include but not limited to: (Emergency Response duties and/or coverage, Department duty coverage and/or call out, and positions outside of department in support of outage activities etc.). Minimum Qualifications Bachelor's degree in Engineering or equivalent technical degree Minimum of 10 years of professional relevant nuclear power or North America Electric Reliability Corporation (NERC) professional experience and exceptional performance Superior regulatory/technical expertise in a specific area (e.g., licensing actions, reportability, performance improvement, etc.) and recognized regulatory resource (internal/external) Strong written and oral communication skills Approval of VP Licensing & Regulatory Affairs required to obtain this classification (and recommendation of Sr. Manager Licensing /Director-Licensing/Regulatory Assurance Manager and Site Vice President, as applicable) Maintain minimum access requirement or unescorted access requirements, as applicable, and favorable medical examination and/or testing in accordance with position duties Preferred Qualifications Previous Senior Reactor Operator (SRO) license/certification Advanced technical degree or related coursework Highly seeking previous Nuclear, NRC, Regulatory or Licensing experience