Director, GMP Operations

Century Therapeutics, Inc.; Branchburg Township (NJ); Vor Ort; USD 195.000 - 218.000; Vollzeit

Zusammenfassung

Century Therapeutics, Inc. in New Jersey seeks a Director, GMP Operations to provide strategic and operational leadership for Century’s GMP manufacturing facility, including validation, warehouse operations, and CQV processes.

You will own site systems, oversee inventory, and ensure timely supply for Phase 1 clinical trials, collaborating across Quality, Supply Chain, MSAT, EHS and Facilities. This on-site role offers a competitive salary and strong benefits.

Qualifikationen

• Advanced knowledge of cGMP/biopharmaceutical regulations.
• Advanced cell therapy manufacturing experience including aseptic processing, media prep, cell banking, culture, and cryopreservation.
• Strong knowledge of current validation best practices, including government regulations and GxPs.
• Experience with ERP systems for inventory management and QMS for master batch records.
• Experience leading teams or vendor relationships is a plus.
• Ability to read, write and interpret technical/quality documents (SOPs, deviations, CAPAs).
• Proven ability to lead in a fast-paced, hands-on environment and adapt priorities.
• Ability to work in controlled clean rooms with appropriate PPE.

Aufgaben

• Lead cell therapy GMP operations in Century’s GMP facility.
• Own and maintain site systems including inventory management and validation.
• Partner cross-functionally to ensure supply of clinical material for Phase 1 trials.
• Create, review, and approve SOPs, batch records, material specifications, and validation reports.
• Implement a Process Validation lifecycle including Aseptic Process Simulation for cell therapy manufacturing.
• Build a collaborative environment with decisive decision making and accountability.
• Ensure timely closure of deviations, CAPAs, and change controls.
• Build cross-functional relationships with Quality, Supply Chain, MSAT, EHS and Facilities.

Kenntnisse

GMP operations leadership

cell therapy manufacturing

validation & CQV

SOPs & batch records

cross-functional collaboration

Ausbildung

BS in biopharmaceutical field

MS in biopharmaceuticals

Tools

ERP systems

QMS electronic system for MBRs

Jobbeschreibung

About Century Therapeutics:
Century Therapeutics (NASDAQ: IPSC) is a biotechnology company advancing a pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies with the potential to meaningfully address autoimmune diseases, including type 1 diabetes, and cancer. The company’s therapies are derived from its iPSC cell foundry and leverage its novel immune evasion engineering technology, Allo-Evasion. Century believes its approach to developing off-the-shelf cell therapies will expand patient access and provide advantages over existing cell therapies which will ultimately advance the course of care.

Role:

The Director, GMP Operations will provide strategic and operational leadership in the areas of GMP operations, including validation, warehouse operations, and overall facility readiness for Century’s cell therapy GMP clinical manufacturing facility. The candidate will develop and maintain site specific manufacturing infrastructure, policies, and systems and will provide operational oversight for the manufacture and supply of cellular therapy clinical products. This position will play a critical role in the Manufacturing facility and has responsibility for leading all site-level manufacturing, inventory, and Commissioning, Qualification, Validation (CQV) processes and procedures.

The work expectation for this role is 5 days per-week on-site.

The expected annual salary range for this role is approximately $195,000 - $218,000 depending on experience. Additional benefits offered include but are not limited to an annual performance-based bonus (prorated by start date), medical, dental, and vision insurance, matching 401K plan, and 20+ days per-year of PTO (prorated by start date). Additionally, employees not requiring sponsorship are preferred.

Requirements

• Lead cell therapy GMP operations in Century’s GMP facility.
• Own and maintain site systems including inventory management and validation.
• Partner cross functionally to develop procedures to ensure supply of clinical material for Phase 1 clinical trials.
• Create, review, and approve documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
• Implement and maintain a Process Validation lifecycle, including design and implementation of Aseptic Process Simulation activities for cell therapy manufacturing.
• Build a collaborative environment that fosters decisive decision making and accountability.
• Ensure on time closure of deviations, CAPAs, and change controls, as necessary.
• Build effective cross-functional relationships with Quality, Supply Chain, MSAT, EHS and Facilities.

Qualifications:

• BS or higher degree in a biopharmaceutical industry-related discipline
• BS with 15+ years of experience or MS with 12+ years in developmental biopharmaceutical products with at least 5 years in a manufacturing leadership role.
• Experience in cell therapy highly preferred

Requirements:

• Advanced knowledge of cGMP/Biopharmaceutical regulations.
• Advanced understanding and experience with cell therapy manufacturing including aseptic processing, media preparation, cell banking, cell culture, and cryopreservation.
• Possesses strong knowledge of current validation best practices, including governmental regulations and GxPs.
• Experience with ERP systems for inventory management and QMS electronic system for master batch records
• Experience managing teams or vendor relationships a plus.
• Ability to read, write and interpret technical and quality documents, such as safety procedures, batch production records, standard operating procedures (SOPs), change requests, deviations, and corrective and preventative action plans (CAPAs).
• Proven ability to work, communicate, and lead effectively in a fast-paced and hands-on environment, and to communicate effectively.
• Ability to change priorities in response to company demands while continuing to deliver results.
• Must have the ability to work in controlled, restricted environments and clean rooms with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
• Ability to don cleanroom garments and personal protective equipment in designated areas which cover head, parts of the face, core body, and legs/feet.

Century Therapeutics is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Century Therapeutics via email, the internet, or directly without a valid written search agreement for this role, and without having been asked to participate in this by Talent Acquisition, will be deemed the sole property of Century Therapeutics, and no fee will be paid in the vent the candidate is hired. Firms not authorized to submit candidates will not be eligible for any fee or ownership claim.

Century Therapeutics Inc. is an Equal Employment Opportunity/Affirmative Action Employer - Minority/Female/Disability/Veteran. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status or any other characteristic protected by federal, state, or local law.