Larimar Therapeutics
Philadelphia, Pennsylvania
Description: The Company: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), 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 assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. 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 to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position: Director, Quality (GCP/GCLP/GVP) Reports to: Sr. Director, Quality Job Responsibilities: Position Overview: The Director, Quality (GCP/GCLP/GVP) will play a key role in shaping and strengthening Larimar's Quality Management System and advancing quality oversight across clinical product development and clinical studies. In this highly visible role, the candidate will collaborate cross-functionally to proactively manage GCP/GCLP/GVP regulatory risks, support inspection readiness, and continuously improve quality standards utilizing insights from inspections, audits, and evolving regulatory landscapes. This position will also assist with management of internal quality systems and processes while ensuring compliance with Larimar requirements and relevant global GCP, GCLP and GVP regulations and guidelines. The Director, Quality (GCP/GCLP/GVP) works with all members of the Quality team, including relevant internal contractors, to ensure quality compliance internally and among the company's contractors, CROs, service providers, etc. to enable development, regulatory approval, and commercialization of the company's products. This role reports to the Sr. Director, Quality. Key Responsibilities: Will include but are not limited to: Develops, implements, and executes the risk-based audit strategy for Clinical and Pharmacovigilance programs. Oversees/leads the execution and completion of external audits of GCP/GCLP/GVP vendors and clinical trial sites, including collaboration with the business sponsors to share audit findings. Leads internal GCP/GCLP/GVP audits. Collaborates with Quality representatives at Larimar's CROs and service providers to ensure the appropriate Quality Agreements have been developed and implemented in support of Larimar's clinical studies. Develops and monitors Larimar's Risk Management Program for clinical studies. Ensures reporting of potential or confirmed violations to regulatory authorities, as appropriate. Provides Good Clinical Practices (GCP) guidance and training to internal teams Manages evaluation of new GCP/GCLP/GVP related regulations and potential implications for Larimar. Supports the development and/or revision of Quality, Clinical, and Pharmacovigilance processes and procedures including SOPs and risk assessment tools ensuring consistency and compliance with relevant GCP, GCLP, CLIA, FDA, EMA, and other global regulatory requirements. Directly supports inspection readiness preparation (core team) and supports regulatory agency inspection(s). Assists in compiling information for regulatory submissions and conducting quality reviews and auditing of regulatory submissions, as requested. Supports quality system monitoring reviews. Supports other Quality activities, as required. Approximately 15-20% travel required Requirements: Qualifications: Bachelor's degree in life sciences with a minimum of 10+ years experience in a Quality role supporting Clinical Operations and/or Pharmacovigilance departments within a biotechnology or pharmaceutical environment Experience managing GCP/GCLP/GVP quality processes, including risk management activities Demonstrated experience managing GCP inspections, including preparation and response activities Minimum of 3 years experience performing GCP/GCLP/GVP audits or comparable GxP audit experience Expert knowledge of GxP systems, quality principles, and GCP/GCLP/GVP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH) and ability to translate understanding to practice Demonstrated ability to initiate process improvements and take initiative is required Must possess a strong attention to detail while having the ability to work independently and collaboratively, as required, in a fast-paced environment Benefits: Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. 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 relationship with all candidates and 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. PI8ba7598b675f-7244
Description: The Company: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), 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 assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. 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 to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position: Director, Quality (GCP/GCLP/GVP) Reports to: Sr. Director, Quality Job Responsibilities: Position Overview: The Director, Quality (GCP/GCLP/GVP) will play a key role in shaping and strengthening Larimar's Quality Management System and advancing quality oversight across clinical product development and clinical studies. In this highly visible role, the candidate will collaborate cross-functionally to proactively manage GCP/GCLP/GVP regulatory risks, support inspection readiness, and continuously improve quality standards utilizing insights from inspections, audits, and evolving regulatory landscapes. This position will also assist with management of internal quality systems and processes while ensuring compliance with Larimar requirements and relevant global GCP, GCLP and GVP regulations and guidelines. The Director, Quality (GCP/GCLP/GVP) works with all members of the Quality team, including relevant internal contractors, to ensure quality compliance internally and among the company's contractors, CROs, service providers, etc. to enable development, regulatory approval, and commercialization of the company's products. This role reports to the Sr. Director, Quality. Key Responsibilities: Will include but are not limited to: Develops, implements, and executes the risk-based audit strategy for Clinical and Pharmacovigilance programs. Oversees/leads the execution and completion of external audits of GCP/GCLP/GVP vendors and clinical trial sites, including collaboration with the business sponsors to share audit findings. Leads internal GCP/GCLP/GVP audits. Collaborates with Quality representatives at Larimar's CROs and service providers to ensure the appropriate Quality Agreements have been developed and implemented in support of Larimar's clinical studies. Develops and monitors Larimar's Risk Management Program for clinical studies. Ensures reporting of potential or confirmed violations to regulatory authorities, as appropriate. Provides Good Clinical Practices (GCP) guidance and training to internal teams Manages evaluation of new GCP/GCLP/GVP related regulations and potential implications for Larimar. Supports the development and/or revision of Quality, Clinical, and Pharmacovigilance processes and procedures including SOPs and risk assessment tools ensuring consistency and compliance with relevant GCP, GCLP, CLIA, FDA, EMA, and other global regulatory requirements. Directly supports inspection readiness preparation (core team) and supports regulatory agency inspection(s). Assists in compiling information for regulatory submissions and conducting quality reviews and auditing of regulatory submissions, as requested. Supports quality system monitoring reviews. Supports other Quality activities, as required. Approximately 15-20% travel required Requirements: Qualifications: Bachelor's degree in life sciences with a minimum of 10+ years experience in a Quality role supporting Clinical Operations and/or Pharmacovigilance departments within a biotechnology or pharmaceutical environment Experience managing GCP/GCLP/GVP quality processes, including risk management activities Demonstrated experience managing GCP inspections, including preparation and response activities Minimum of 3 years experience performing GCP/GCLP/GVP audits or comparable GxP audit experience Expert knowledge of GxP systems, quality principles, and GCP/GCLP/GVP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH) and ability to translate understanding to practice Demonstrated ability to initiate process improvements and take initiative is required Must possess a strong attention to detail while having the ability to work independently and collaboratively, as required, in a fast-paced environment Benefits: Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. 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 relationship with all candidates and 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. PI8ba7598b675f-7244
Constellation Energy
Warrenville, Illinois
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
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