Senior Manager
4 weeks ago
The Senior Manager - Parenteral Drug Product Manufacturing & Development will be responsible for managing all aspects of drug product manufacturing operations at Contract Manufacturing Organizations (CMOs) to manufacture clinical parenteral medicines according to approved protocols, regulations, and timelines. This includes partnering with Chemical Development to implement new production processes at CMOs, managing key manufacturing metrics and goals, and driving continuous improvement initiatives to meet patient and business needs.
Key Responsibilities
- Manage all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved protocols, regulations, and timelines
- Partner with Chemical Development to implement new production processes at CMOs, including formulation, sterilization, filling, and lyophilization
- Manage key manufacturing metrics and goals, and drive continuous improvement initiatives to meet patient and business needs
- Rapidly and accurately communicate issues to Senior Leadership, and resolve manufacturing and facility issues to mitigate any supply disruptions to our patients
Requirements
- BS/MS in Biochemistry, Chemistry, Engineering, or related discipline, and 5+ years of experience in a cGMP setting
- In-depth experience in pharmaceutical operations associated with aseptic processing
- Experience working to standards required for regulatory compliance of Aseptic Processing facilities
- Understanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities, and associated pharmaceutical processes
- Experience with the drug product formulation process and optimization
- Excellent verbal and written communication skills, and ability to work effectively managing CMOs
What We Offer
- Competitive base compensation range of $120,000 to $150,000
- Eligibility for a company bonus based on individual and company performance
- Long-term incentive compensation and company vehicles depending on the position's level or other company factors
- Comprehensive benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, employee assistance program, tuition reimbursement program, and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance
- Time off pursuant to our sick time policy, flexible vacation policy, and parental leave policy
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