Bachem

Your Responsibilities The Sr. Validation Engineer / Quality Engineering (QE) fulfills a critical role in GMP operations, supporting the qualification of equipment, facilities, utilities, and cleaning validation activities for API and PMO manufacturing. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations. Your Tasks Oversee or independently plan and execute qualification (DQ, IQ, OQ, PQ)/ validation activities under the Quality Engineering scope of work Provide qualification / validation guidance and strategy during project planning and development phases Support / review the change control process, performing risk assessments, and assessing the adequacy of validations requirements Address deviations, and generate CAPAs, as required Develop, plan and perform cold storage unit validation / temperature mapping using existing data loggers, including managing the calibration of the units Review periodic utility system verifications / monitoring (purity test) Review periodic cleanroom pressure differential monitoring Conduct and document investigations related to validation activities Develop and execute cleaning validation protocols and generate validation reports per established acceptance limits and criteria Plan and perform required periodic re-validation / re-qualification activities Perform QA review of equipment calibration documents Draft SOPs and technical reports Train operations staff on protocols, procedures and technical details related to systems, equipment and cleaning processes Demonstrate commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies requirements. Contribute to GMP systems improvements Your Profile Bachelor's Degree in science related field (engineering, chemistry, biology or equivalent) Minimum of 5 years pharmaceutical validation experience, including experience in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports Qualification experience in process equipment, including parts washers, sanitary vessels, lyophilizes, and chromatography systems Experience with data logger equipment Experience with validation / monitoring of clean pharmaceutical utility systems, including purified water and Nitrogen systems Experience with cleanroom validation and HVAC systems Experience with equipment calibration requirements Experience in writing standard operating procedures (SOP) and technical reports Strong knowledge of GMPs, FDA and EU guidance/ requirements related to validation Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel, PowerPoint and Visio Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Coach and mentor validation personnel as well as oversee the activities of contractors / vendors (as necessary) Preferred: Master's degree in science related field (engineering, chemistry, biology or equivalent) Experience with Cleaning Validation Experience with Lean Six Sigma methods: Root cause analysis, failure mode analysis and analyzing / organizing complex technical problems. We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity Nearest Major Market: San Diego

The Project Manager (PM) is responsible for the coordination and proactive management of ongoing active pharmaceutical ingredient (API) manufacturing campaigns for Bachem customers in the biotechnology and pharmaceutical industries. The PM reports into Group Leader or Director and liaises externally with the customers as well as internally with Bachem Sales and site-specific (Torrance or Vista, CA) Operations (QC, QA, Logistics, and Production) teams to ensure that the clients' milestones and deliverables are met. Your Tasks: Proactively and simultaneously manage multiple (5+) generic and new chemical entity (NCE) drug substance manufacturing projects at Bachem Americas for non-GMP, clinical and commercial GMP use Ensure that project deliverables and timelines are met as stipulated in customer purchase orders and agreements/contracts (Non-Disclosure Agreement, Master Supply Agreement, Quality Agreement, Developmental Agreement, Statement of Work) Once project is completed, perform closing activities such as shipping, storage, and invoicing of product Interface with project management functions at other Bachem manufacturing sites (Vista, CA and Bubendorf, Switzerland) to track progress of projects ordered within the Americas Consistently communicate timely and project progress updates and/or issues to customers via email and teleconferences Effectively manage customer review, approval and delivery (where applicable) of manufacturing-related documents (batch records, analytical method and validation protocols/reports, CofA's, and release specifications) Facilitate in project-related discussions both internally and externally and generate meeting notes and action items Serve as liaison between customer contacts and technical staff at Bachem manufacturing sites Provide feedback internally on project-related proposal requests as needed Update Enterprise Resource Planning (ERP) and CRM software to reflect real-time project status/requirements Schedule, organize, and document customer visits (technical and quality/audit-related) to manufacturing sites Collaborate with Contract Manager to ensure the feasibility of compliance within all contracts and agreements Maintain close communication with Sales Team to ensure they are kept informed on project interactions with customers Communicate monthly project status, closing, and financials to Bachem upper management Participate in sales process whenever needed Assist/train sales force and other key personnel in manufacturing capabilities and associated services Special projects will be assigned on occasion Travel may be required as business demands dictate Your Profile: Minimum B.S. in Science (Chemistry, Biochemistry, Biology or similar) field 3-5 years pharm/biotech experience (laboratory, laboratory-related, and/or cGMP manufacturing) 1-3 years of project management experience 1-2 years in customer-facing role, such as Sales, consulting, or Project Management in the pharma, biotech or medical device industry Ability to understand financial aspects of customer accounts (Payment terms, pre-payment requirements, forecasting) Excellent computer/system skills, especially MS Office, CRM (Salesforce), Document Control (Master Control), Document-sharing (SharePoint, ShareFile), ERP (SAP), Online and video-conferencing meetings (Skype); MS Project Excellent written and oral communication skills Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Experience facilitating external and internal team calls and onsite visits to manufacturing sites and capturing required notes and action items Ability to communicate in a proactive and solution-focused manner, including keeping management and stakeholders aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a cross-functional team environment Preferred: M.S. or Ph.D. in Science (Chemistry, Biochemistry, Biology, Bioengineering, or similar) field or MBA PMP certification Drug substance peptide, small molecule, oligonucleotide, or recombinant protein manufacturing experience FDA and/or Global Regulatory and compliance experience CMO or CRO experience Knowledge of contracts and agreements (NDA's, Supply Agreements, Quality Agreements, Request for Proposals) to ensure they are adhered to during project execution Knowledge of Chemistry, Manufacturing, and Controls (CMC) documents having to do with IND and NDA filings and API development Knowledge of packaging and shipping of drug substances domestically and/or internationally and associated Incoterms Familiarity with drug substance characterization analysis (HPLC, UPLC, LC-MS, MS, GC-MS, AAA, CHN) for in-process, release, and stability testing Nearest Major Market: Los Angeles

Your Responsibilities The Chemist (Chem1) function is to develop the peptide manufacture process, manufacture GMP material and perform related activities at Bachem. Your Tasks Perform synthesis process including solution phase and solid phase peptide synthesis, peptide resin cleavage, resin cleavage with HF or other chemical cocktails Perform purification process by chromatography, crystallization and other techniques, and in-process test method Follow approved GMP manufacture directions such as Master Batch Records, Standard Operation Procedures, Standard Test Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities Perform project-planning and initiate raw material order-request. Receive raw materials, coordinate with QA/QC and Material Management for material release and monitor raw material inventories Install, test equipment, operate and maintain equipment for manufacturing and in-process testing. The equipment includes analytical HPLC and prep HPLC system, Lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and others used in manufacture Develop processes for purification of chemicals other than peptides Follow and maintain GMP Documentation System. Investigate any process deviation and write process deviation report. Initiate document change request. Help quality control and assurance unit to maintain equipment calibration program Routinely maintain/organize work areas (Hood, bench, floor, wall, etc.) and other designated areas at the manufacturing facility Develop peptide-manufacturing processes including peptide/protein purification by chromatography, crystallization, and other techniques, and in process test methods Assist QA/QC for monitoring raw material inventories Write Standard Operation Procedures, Standard Test Procedures, Master Batch Records and other related GMP documents Follow SOPs and approved directions to clean equipment used in GMP processes, maintain cleaning log for each equipment, assist in equipment calibration program, and dispose chemical waste generated in the manufacture Monitor compliance of Maintenance and Cleaning procedures of equipment and instruments used in GMP processes by periodically reviewing and signing off on maintenance and cleaning log for each equipment Your Profile BS degree in Chemistry or related field 1-3 years' work experience Experience with HPLC and chromatography May work with hazardous materials and chemicals Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Preferred: Experience with Peptides General lab instrument (MS UV Spectrometry) knowledge and operation experience Knowledge of cGMP and FDA regulations We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: Los Angeles

The Director of Maintenance is responsible for the coordination and direction of Facility and Equipment Maintenance of the Bachem Americas, Inc. facilities in Torrance, California. This position will manage the maintenance programs to ensure full compliance with GMP requirements. The Director will be responsible for development and updating programs including preventative maintenance, capital installation projects, energy conservation programs, Computerized Maintenance Management system, supervision of direct reports, and facility programs support. Your Tasks: Ensure full compliance to policies and guidelines Proactively work to identify equipment replacement needs Develop and implement changes to the Preventive Maintenance (PM) and Predictive Maintenance (PdM) Programs to ensure full compliance Prepare budgets for the Maintenance Engineering department Maintain costs within the budgeted expenses within all areas of control Work with Quality, IT, Engineering and Production Departments to develop and maintain Alarm Logging systems and Trending requirements and provide guidance to ensure continuous monitoring and system improvements Ensure that Federal, State, and Local regulations, including GMP and EHS regulations, are complied with as evidenced by internal audits and inspections from Government Agencies Train, guide, and evaluate employees in the interpretation of company policies, goals, and objectives for the company sites Maintain an adequate workforce to support present needs and plan for departmental requirements in the future Promote good relationships within the department and with other departments within the company Coordinating with all departments in technical matters dealing with plant infrastructure, instruments and equipment Maintain and troubleshoot key equipment and ensure continuous and smooth operation Coordination of maintenance, engineering, and construction activities Cost control of plant related activities, contractors and utilities Direct recurring calibration/certification of equipment and instruments Advise executive management and department managers about improvements, acquisition of buildings and equipment Coordinate and manage building monitor systems, providing system alarms and status through Ethernet solutions Manage/administrate the Computerized Maintenance Management System Monitor all facility and production equipment and/or service as per compliance with in-house Standard Operating Procedures Manage Preventative Maintenance (PM) program; includes schedules, and non-routine repairs Maintain Equipment History files to track maintenance, equipment manuals, and supporting documentation Provide Engineering assessment, user functional requirements and estimates for equipment, utility or facility upgrades Participate as a key member of the management team Responsible for troubleshooting of equipment/facilities; requires 24 hour phone monitoring and possible weekend and after hours response Manage contract service providers; includes training, scheduling, coordination, external SOPs, and documentation of all work in accordance with GMP requirements Must have strong negotiation skills and significant experience in interacting with contractors Submit annual budget proposal to management while taking responsibility for department budget control Review/modify in-house Standard Operating Procedures Train department members in safety and job related functions Supervise regulatory and safety requirements related to departmental functions Travel will be required between Vista Ca. and Torrance Ca Your Profile: Bachelor's Degree in Science or Engineering Minimum of 10 years work experience Technical knowledge of facility equipment, analytical instrumentation, process equipment, and all associated applications Experience in facility and equipment maintenance, troubleshooting, and engineering Experience with equipment and instrument qualification and calibration Ability to Manage and lead a team Proficiency with Technical writing Working knowledge of cGMPs as they relate to a pharmaceutical manufacturing facility Detail oriented with the ability to troubleshoot and resolve equipment problems Proficient in reading schematics and diagrams as well as other written materials Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Experience with Peptides Nearest Major Market: Los Angeles

The Data Specialist is responsible for the collection, statistical analysis and visualization of production data to support the manufacturing team in increasing process performance, robustness and efficiency. The responsibilities of the Data Specialist will include compiling and analyzing data from ongoing and historical manufacturing activities in order to provide actionable information and recommendations to the management team. The Data Specialist will identify and apply appropriate analytical techniques in order to gather data, identify areas of improvement and recommend necessary process controls or other actions to increase process efficiency. They will be working as an individual contributor while reporting to the production department and coordinating with other involved functional areas. The specialist will have a significant impact on manufacturing strategies. Your Tasks: Analyzing selected manufacturing processes, identifying and applying appropriate analytical techniques to gather data, identify areas of improvement, and recommending necessary process controls or other actions to increase process efficiency Managing multiple time sensitive projects to deliver targeted outcomes: Organizing departmental efforts to identify, prioritize, and assess the impact of process parameters of ongoing manufacturing Leading efforts to develop standard data acquisition processes that can be applied to all projects Training other team members to perform data analysis Identifying causes of variability in multi-stage production processes Summarizing analytical results and to effectively communicate recommendations to management Utilizing process maps to illustrate manufacturing processes flow Defining quality metrics to illustrate the impact of process improvement to customers Utilizing trend analysis to identify opportunities for improvement in manufacturing processes Coordinate closely with department directors and managers responsible for executing studies Present findings to stakeholders using PowerPoint, graphs, charts, etc… Ensuring procedures are in full compliance with regulatory requirements Supporting company-wide regulatory compliance through compilation of required data to prepare reports for customers and agencies Participating in FMEA teams to define process risks Supporting Manufacturing departments to draft and review MBPRs, SOPs, deviations, investigations, and other technical documents Tracking CAPAs related to the manufacturing department to ensure that commitments are met within established timelines Working with the Production team to ensure the production department is in full compliance with the Bachem Quality Management system Ensuring all work performed is in compliance with cGMP guidelines Maintaining communication with managers, cross-functional teams, and staff Report to the VP of Manufacturing on process performance of ongoing manufacturing projects Required: BA/BS in Chemistry, Industrial Hygiene, Pharmacology or related field Exposure to reporting tools such as Hyperion/Brio or other higher levels of statistical software Minimum of Six years' experience working in a GMP environment Experience with statistical analysis applied to pharmaceutical manufacturing Understanding of analytical chemistry such as HPLC, LC-MS, GC etc… Knowledge of FDA regulations Excellent written and oral communication skills Expert computer knowledge, including Microsoft Word, Excel, PowerPoint and Project with mastery of spreadsheets and word processing Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve technical and analytical problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Master's Degree Experience with project management and oral presentations Knowledge of regulatory and ISO standards Nearest Major Market: Los Angeles