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Contract Manufacturing Specialist

Thousand Oaks, CA
Top 3 Must Have Skill Sets:     
  • Must have previous Amgen experience, exp with NC's and CAPA's.
  • Self-starter, works independently
  • Ability to manage root cause investigations and corrective actions in a timely manner with good communication skills (live discussions, emails, presentations, technical writing, etc.)    
    
Day to Day Responsibilities:
  • Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
  • Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
  • Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
  • Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out.
  • Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.


Ideal Candidate:
  • Must have previous Amgen experience, exp with NC's and CAPA's.
  • Self-starter, works independently, corporate professional that can navigate at all levels of organization and with external suppliers, objective and the ability to manage root cause investigations and corrective actions in a timely manner, good communication skills (live discussions, emails, presentations, etc), good story telling skills to appropriately document investigations and follow up in Quality Management Systems, flexible and comfortable working with ambiguity, can manage multiple priorities with deadlines, knows when to escalate issues, has an Amgen-first mindset but can also represent suppliers to the internal org, knowledge of the biopharm manufacturing process, knowledge of the drug commercialization process, knowledge of GXPs, understands a regulated environment, patient first mentality, Quality mindset, self-awareness, works well in cross-functional teams
  • Background: experience/success in managing investigations in a technology field (preferably biotech or pharm), experience in working in a matrixed environment, experience working for a global company and can appreciate diversity, different cultures and time zones, experience working with global sites, experience in Manufacturing and/or Quality
  • Years of experience/education: bachelors in biotech, science, engineering, etc; 4-6 years experience in Manufacturing and/or Quality

Summary:
  • Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
  • Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
  • Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
  • Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out.
  • Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.

Preferred Qualifications:
  • Bachelor’s in Business Administration, Engineering, or Science-related field
  • 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment
  • 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
  • 2+ years of project management experience leading multi-functional and/or multi-location team
  • 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products

Competencies
  • Demonstrated matrix management and influencing skills
  • Manufacturing and cGMP knowledge / experience
  • Demonstrated negotiation skills
  • Operational Excellence proficiency and ability to drive continuous improvement
  • Financial/budgeting knowledge and business acumen
  • Proficient project management skills
  • Problem-solving and critical thinking
  • Understanding of contractual requirements
  • Technical writing and multi-level communication skills
  • Demonstrated ability to lead effectively in collaborative/team environment
  • Demonstrated ability to take initiative, drive action, and work under minimum supervision
         "This posting is for Contingent Worker, not an FTE"
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