Coherus Biosciences, Inc. is focused on delivering high quality biosimilar therapeutics that will expand the access of important medicines to patients worldwide. 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.  

In this key position, you will be primarily responsible for ensuring adequate clinical product supply availability for multiple ongoing global clinical studies across all phases of clinical development. You will be part of the Manufacturing group and be responsible for clinical forecasting and projections, drug product packaging and labeling, procurement of comparators, and oversight of all vendors relevant to finished clinical supply.  This position also works very closely with Clinical Operations and Quality Assurance departments as well as outside vendors.

• Oversee all aspects of clinical product packaging and distribution, from fill to clinical sites

• Ensures that clinical drug is consistently delivered to the clinical sites on time.

• Provide oversight and direction to the 3PL and other relevant vendors.

• Responsible for ensuring 3PL vendors meet requirements as per business plan.

• Work with the 3PL to ensure packaging and labeling meet internal expectations and FDA/ICH regulatory requirements.

• Translates clinical study protocol requirements into demand for drug product with in a clinical study.

• Use simulation tools and supply chain expertise/models to design an optimized, flexible supply chain for individual studies.

• Collaborate with CROs and establish user specifications for the IXRS clinical supply chain management.

• Identify, select and audit potential new clinical supply chain vendors as necessary.

• Ensure critical corporate standards are met in both quality and compliance with cGMP standards.

• 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.

• Investigate/resolve clinical supply non-conformance events and implement CAPAs as necessary.

• Prepare yearly budgets. Process quotes, invoices and procure VAT return.

• Establish and/or revise SOPs and documentation as necessary.

• Travel as required to manufacturing sites located throughout the world

• Person-in-plant during packaging runs.

Experience, Education, Training, Traits:

• BS is required.

• Minimum of 5 years’ clinical supply chain experience in the biopharmaceutical / pharmaceutical industries – biopharmaceutical experience preferred.

• Must have knowledge of applicable Quality and Regulatory guidelines.

• Must have experience with guiding GMP investigations at 3PLs.

• Must work well in cross-functional teams and be able to communicate effectively with external partners, peers, and senior management.

• Prior experience managing third party 3PLs relationships and as person in plant during packaging runs.

• Must have strong negotiating and interpersonal skills, and the ability to clearly present recommendations.

• Excellent decision-making, leadership, interpersonal, written and verbal communication skills.

• Must have strong computer skills, including all MS Office applications.

  Travel:

  Ability to travel domestically and internationally, up to 15%

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.