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Associate Director, Finished Product

Redwood City, CA
Title:                        Associate Director, Finished Product
Reports to:          Executive Director, Drug & Finished Product
Location:              Redwood City, California
Classification:  Exempt
 

Overview:

The Associate Director of Finished Product supports commercial and pre‑commercial packaging component development, technology transfer, and labeling/artwork processes in addition to supply chain and inventory management with Coherus’ supply operations.  This role works closely with Contract Manufacturing Organizations (CMOs), internal cross‑functional teams, and external suppliers to ensure compliant, efficient, and high‑quality manufacturing, labeling, packaging, and supply logistics operations under cGMP standards.


Responsibilities:

Finished Product / Combination Product Process Development

  • Lead technology transfers for finished product manufacturing.
  • Ensure CMO execution aligns with development procedures and best practices.
  • Design and execute process characterization studies.
  • Support product serialization requirements across global markets.
  • Author CMC sections of regulatory submissions and act as technical contact during agency interactions.

Assembly, Labeling & Packaging Operations

  • Serve as technical lead for CMO operations related to assembly, labeling, and packaging.
  • Support deviations, CAPAs, change controls, process monitoring, and process improvement initiatives.
  • Represent the company as person‑in‑plant during manufacturing and packaging operations.

Labeling / Artwork Management

  • Oversee development, review, and approval of clinical and commercial labeling with internal and external partners.
  • Ensure compliance with regulatory and SOP requirements in labeling content.
  • Support development and improvement of tools and processes for label content, graphics, translation, and proofreading workflows.

Quality & Compliance

  • Ensure adherence to cGMP, ICH, EMA, FDA, OSHA, and internal corporate quality standards.
  • Ensure compliance with device/combination product design control and labeling requirements.
  • Support audits, inspections, and quality initiatives across supply chain and finished product operations.
  • Travel domestically and internationally up to 25% as required.

Commercial & Pre‑Commercial Supply Chain Management

  • Generate production and storage purchase orders for CMO sites per the master production schedule.
  • Coordinate daily shipments of bulk drug substance, drug product, and finished goods.
  • Track commercial and pre‑commercial sample shipments and proactively resolve logistics issues.
  • Maintain master production schedule data, including part numbers, lot numbers, CMO locations, and quantities.
  • Execute daily inventory transactions: stock transfers, work orders, adjustments, disposals.
  • Manage drug returns for redistribution or disposal.
  • Review inventory reports for quantity, expiration, and lot status; rebalance inventories across CMOs.
  • Investigate and resolve inventory discrepancies.
  • Escalate raw material shortages that may impact supply continuity.
  • Coordinate domestic and international shipments per company SOPs and compliance requirements.
  • Support logistics‑related studies, SOP development, and shipping validations for product launches.

 

Qualifications:

Required Education & Experience

  • BS in packaging engineering, mechanical engineering, or related field preferred.
  • Minimum 8 years’ packaging experience in biopharmaceuticals

Preferred Qualifications

  • Strong knowledge of transportation/logistics and import/export compliance.
  • Experience working within compliant import/export programs (pharma/biopharma/chemical).
  • Strong understanding of GMPs, biologics manufacturing, aseptic processing, and pharmaceutical operations.
  • Experience with label design, content management, translation workflow, and graphics/approval systems.
  • Knowledge of combination product/device design control and regulatory expectations.
  • Experience managing CMOs and acting as person‑in‑plant.
  • Strong communication, leadership, and stakeholder management skills.
  • Ability to manage multiple priorities under tight timelines.
  • Strong computer proficiency, including MS Office; experience with statistical software (JMP, Minitab) a plus.

 

The Base Salary Range for this position is $170,000 to $200,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.

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