Responsible for managing drug product and drug substance manufacturing at CMOs to support clinical development programs. Provide technical expertise on process development, optimization, scale up and transfer.
- Manage GMP manufacturing of clinical stage drug products and drug substances at CMOs.
- Provide technical expertise in process development, optimization, scale up and transfer.
- Provide technical expertise in creating manufacturing batch records, review manufacturing batch records and other manufacturing documents.
- Prepare and/or oversee the preparation of the CMC section(s) of IND submissions and other filings as needed.
- Interact closely with counterparts in Quality Assurance, Regulatory, Quality Control, Project Management and Finance, and participate in regular project and CMC review meetings to ensure effective communication and sharing of information.
- May perform other related duties as required and/or assigned, including providing advice and technical support to the broader Operations department.
Nature and Scope:
Interacts with various levels of personnel internally, and typically a similar level externally requiring the ability to clearly understand and communicate policies and procedures. Requires a solid working knowledge relevant to the applicable field. Job encounters problems of limited scope and moderate complexity with occasional variations from the norm. The incumbent receives instruction on new assignments and limited instruction on routine work. Errors in work could cause delays and financial loss.
B.S or M.S. degree in Chemistry, Pharmaceutical Sciences or a related discipline.
Experience and Abilities:
- 5-8 years of experience in GMP drug product and/or drug substance manufacturing.
- 3-5 years of experience working with contract manufacturing facilities in managing manufacturing projects to meet company requirements and timelines.
- In-depth scientific knowledge and experience in drug product and/or drug substance manufacturing.
- Knowledge of GMPs and regulatory requirements as related to formulation development and drug product manufacturing.
- Experience in manufacturing of sterile products is highly desired.
- Previous supervisory experience a plus.
Equal Opportunity Employer/Females/Minorities/Veterans/Disability
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