SeattleRecruiter Since 2001
the smart solution for Seattle jobs

Associate Director, Raw Materials Global MSAT Cell Therapy

Company: Celgene
Location: Seattle
Posted on: February 16, 2020

Job Description:

Summary: This leadership role will lead a global team of MSAT process engineers that is responsible for technical oversight of the raw materials and key suppliers within the Cell Therapy Development & Operations (CTDO). The scope of this role includes media, buffers, reagents and critical product contact equipment for the CAR-T drug product operations and suppliers of key raw materials for the drug product manufacturing processes throughout the product/process lifecycle stages. This role will be global. This team will be responsible for management of raw material suppliers, deviations, change notifications and troubleshooting/ investigations. This role will also provide a strategic direction for the implementation of dual sourcing strategies for products. A key component of this role will be to work with supplier quality and technical development groups to establish a robust supplier oversight program and develop effective working relationships with technical counterparts in the key suppliers. Responsibilities will include, but are not limited to, the following:

  • Participate in the raw material supplier selection process by evaluating supplier technical capabilities against cell therapy manufacturing requirements
  • Ensure routine technical support of the vendors for deviation management, batch record reviews to ensure that technical issues stay off the critical path for reliable supply
  • Participate in the appropriate internal and joint governance meetings
  • Provide technical support for network wide raw material issues that impact quality and supply of raw materials. Develop appropriate mitigations and corrective actions
  • Ensure that the technical changes for the raw materials are coordinated across the network
  • Conduct risk assessments and develop mitigation plans for significant technical risks at key raw material suppliers
  • Provide raw material master plans for all critical materials.
  • Review, approve sections of the regulatory dossier, briefing books or communications to health authorities with respect to raw material controls
  • Develop risk based strategies for the technical oversight of raw material suppliers
  • Collaborate with Manufacturing, Process Development, Analytical R&D, Quality Operations, MSAT network to ensure raw material oversight.
  • 25-50% travel required Skills/Knowledge Required : PhD in Biological Science, Biomedical Engineering, Chemical Engineering, or related discipline with 5 years development / manufacturing technologies experience, or BS/MS with 10 or more years development / manufacturing technologies for biologics, or vaccines. A combination or related experiences/degrees may also be acceptable. A minimum of 2 years raw material experience is required (single use systems and/or media/ buffer/ reagents) Established track record of success, sound technical qualifications and knowledge in process and analytical transfers. Cell therapy development or related field, aseptic manufacturing, and validation experience a plus. Excellent cross-functional skills including work with accountability to multiple stakeholders. Experience working with multiple suppliers across a range of categories (filters, resins, regents, media, single use components, excipients and other specialized critical raw materials) Strategic thinker with excellent problem solving and conflict resolution skills. Experience managing a technical team is required. Experience with a variety of regulatory agencies and compendial requirements is strongly preferred. Ability to foster a strong team-first environment with the ability to lead multiple projects. Self-motivation, excellent time management, organizational, written and oral communication skills. Associated topics: buyer, commodity, distribution, material, plastics, provider, purchase, raw material, supplier, supply chain

Keywords: Celgene, Seattle , Associate Director, Raw Materials Global MSAT Cell Therapy, Healthcare , Seattle, Washington

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Labor & Delivery - L&D RN - Travel (Bellingham)
Description: Registered Nurse.
Company: HealthCare Traveler Jobs
Location: Bellingham
Posted on: 02/27/2020

Travel RN-Labor and Delivery
Description: ul br li RNnetwork has an excellent travel opportunity for a provider experienced in the following specialty: RN-Labor and Delivery. This opportunity
Company: RNnetwork
Location: Olympia
Posted on: 02/27/2020

Supervisor Auburn Oncology Clinic- RN
Description: Job Description The reasons to work at MultiCare are as unique as the people who do. Join us for the professional challenges you seek. In the settings you prefer. With schedules that fit your life. Learn (more...)
Company: MultiCare
Location: Tacoma
Posted on: 02/27/2020


Hematology/Oncology Physician, 1.0 FTE
Description: Summary Kaiser Permanente-Washington Permanente Medical Group- is seeking a Full Time 1.0 FTE Hematology/Oncology Physician to join our Olympia Medical Center team in Olympia, Washington. You will be (more...)
Company: Washington Permanente Medical Group
Location: Olympia
Posted on: 02/27/2020

Registered Nurse - RN - Home Health
Description: REGISTERED NURSE - RN - HOME HEALTH--CareerStaff Unlimited is looking to hire a motivated, independent Registered Nurses RN with good time management for a full-time home health contract position in (more...)
Company: CareerStaff Unlimited
Location: Lacey
Posted on: 02/27/2020

Doctor of Veterinary Medicine
Description: Description: Locum Veterinarian Summary of Job Purpose and Function The primary purpose and function of the Relief Veterinarian is to provide preventative care, diagnosis and treatment of diseases and (more...)
Company: Banfield Pet Hospital
Location: Lacey
Posted on: 02/27/2020

RN Nurse Residency Program - Emergency Department
Description: Requisition Number 20-0126 Post Date 2/10/2020 Job Type Full-time Title RN Nurse Residency Program - Emergency Department City OLYMPIA State WA Description Position Summary: The Registered Nurse Resident (more...)
Company: CAPITAL MEDICAL CENTER
Location: Olympia
Posted on: 02/27/2020

Staff RN - Good Samaritan Hospital ICU
Description: Better health care starts with you. br br Health care has changed a lot since MultiCare opened its first hospital more than a century ago. And today, things are changing faster than ever. But one (more...)
Company: MultiCare
Location: Tacoma
Posted on: 02/27/2020

Doctor of Veterinary Medicine - #0371 Lacey
Description: Description: Doctor of Veterinary Medicine Banfield aspires to be a practice where as a team, we make a positive impact on pet health care in hospitals, communities, and the field of veterinary medicine. (more...)
Company: Banfield Pet Hospital
Location: Lacey
Posted on: 02/27/2020

FT Nursing Faculty Tenure Track
Description: Full-Time Nursing Faculty, Tenure Track APPLYLocation Bellingham, WAJob TypeFull-time FacultyDepartmentAdjunct Academic Resources Health ProfessionsJob Number00291DescriptionWhatcom Community College (more...)
Company: Whatcom Community College
Location: Bellingham
Posted on: 02/27/2020

Log In or Create An Account

Get the latest Washington jobs by following @recnetWA on Twitter!

Seattle RSS job feeds