Coherus BioSciences
Asst. Director, Drug Product Manufacturing & Logistics
Redwood City, CA, United States · Director
Sponsorship not specifiedDetected 4452 days ago
LogisticsInventory ManagementGMPFDA RegulatoryLeadershipCommunicationMicrosoft OfficeOSHA
About the role
- Also coordinates drug product materials planning, control, inventory management, and GMP shipping functions.
- Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:
- Provide technical expertise and consultation for CMO.
Responsibilities
- Formed in 2010, Coherus has developed a unique, collaborative business model that leverages the leadership team's deep product development expertise and the expertise of a network of strategic partners to develop therapeutics of the highest quality.
- Work with CMO to perform process monitoring, trending and improvement for commercial drug products
- Maintain raw material policies, procedures and risk mitigation strategies with CMOs.
Requirements
- Travel as required to manufacturing sites located throughout the world
- Must have knowledge of applicable Quality and Regulatory guidelines.
- Must have experience with guiding GMP investigations at CMOs.
- Must have strong negotiating and interpersonal skills, and the ability to clearly present recommendations.
- Must have strong computer skills, including all MS Office applications.
- Experience with device development controls including Device History Files (DHFs) and Product Requirement Specifications desirable but not required.
- Ability to travel domestically and internationally, up to 25% and for short-term assignments (3 months) up to 50%.
Nice to have
- Minimum of 5 years' drug product experience in the biopharmaceutical / pharmaceutical industries - biopharmaceutical experience preferred.
Skills
- Excellent decision-making, leadership, interpersonal, written and verbal communication skills.
Benefits
- Our Company offers excellent benefits including medical, dental, vision, life, short and long term disability plans, 401k, FSA, vacations, paid holidays and health club reimbursement.
Company info
- Ensure compliance with federal (FDA, DEA, EPA, OSHA), state and local regulations and adherence to all company policies and procedures relating to Good Manufacturing Practices, EH&S practices, etc.
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This listing is sourced directly from Coherus BioSciences's careers page and normalized into a canonical job model.