A brief overview
The individual in this role utilizes their experience and education to provide day-to-day guidance, direction, support, and technical development and leadership to an assigned manufacturing team. Activities include implementing and monitoring all activities in the assigned work area to ensure production schedules, manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs). Additionally, this individual is responsible for training team members in the technical aspects of equipment use and applying chemistry expertise to troubleshooting activities. This individual reviews documentation, and ensures compliance with policies and procedures, including, but not limited to timekeeping, meal and rest periods, environmental health and safety (EHS), and 5S guidelines. The individual in this role ensures seamless transfer of information and responsibilities across shifts and between areas, and identifies and leads continuous improvement efforts that reduce waste and increase operational efficiency.
What you will do
- Execute and support all production stages which include but are not limited to; synthesis, cleavage, cyclization, conjugation, purification, reconstitution, lyophilization and in-process analytics. Sign off on steps requiring supervision, diagnose and troubleshoot equipment issues, make data-based decisions and escalate to appropriate parties when necessary.
- Provide technical training and guidance on equipment, SOPs, and chemistry processes to support the ongoing development of each member of the team. Ensures that all team member Master Control requirements are met in a timely manner. Maintains training and certification records for team members, as needed.
- Install, operate and maintain equipment for production and in-process testing. The equipment includes but is not limited to analytical HPLC/UPLC, prep. HPLC systems, lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, ovens, washing systems and others used in manufacturing.
- Schedule work assignments and ensure team members are able to take timely rest breaks and meal periods and that all applicable hours are accurately captured on work orders. Stand in for team members to cover breaks or lunches to ensure that a process continues, as needed.
- Actively present in the labs to ensure that operations are running smoothly, and safety and compliance requirements are met. Ensure operators are trained properly on the required standards of operations; BPR, SOPs, STMs, utilization, Safety standards, 5S standards, compliance, etc. Approaches daily activities with a continuous improvement mindset. Regularly identifies improvement initiatives and involves team members in ongoing improvement activities.
- Ensure availability and safe, efficient use of the instruments, raw materials and other resources while scheduling production activities and communicating with all responsible departments involved.
- Review BPRs, logbooks, other quality documents, as needed, but at least once daily. Act as a witness to procedures as required. Provide constructive feedback to Managers regarding team members performance.
- Initiate, investigate and close quality events (Deviation, CAPA, etc.) in a timely manner. Support investigations and implementation of corrective actions with technical knowledge.
- Ensure seamless transfer of information and responsibilities across shifts and between areas. Plan, attend and lead production huddles meetings representing production team, bringing knowledge of processes, equipment and schedule, as needed.
Qualifications
- Bachelor's Degree Organic Chemistry, Biochemistry, or the equivalent
- Master's Degree Organic Chemistry, Biochemistry, or the equivalent (preferred)
- 4-6 years pharmaceutical manufacturing
- 1-3 years experience in cGMP manufacturing and the related documentation standards, including safety, health and compliance regulations as specified by federal, state and local governments (preferred)
- Thorough understanding of all manufacturing stages and in-process analytical methods
- Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods. Knowledge of solvent, waste and materials flow is required.
- Familiar with and fully capable of operating and training on scientific manufacturing equipment and utilities
- Experience working safely with hazardous materials and hazardous waste.
- Advanced computer knowledge, including Microsoft Office applications. SAP experience (preferred)
- Ability to work late shifts on a continuous basis and be flexible of working hours based on business needs which may include some nights and weekends.
Base Salary Range: $83,680 - $115,060
Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.
Total Rewards
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We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.
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Corporate Social Responsibility
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Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness.? EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.
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Bachem Americas is an Equal Opportunity Employer
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All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status
