At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage it reflects who we are and the environment we are creating.
 

POSITION SUMMARY:

The incumbent will support the ongoing operation of the Manufacturing, Science and Technology team within the manufacturing site.  This role will assist the receipt of technology transfers into manufacturing, and critical manufacturing support activities including investigations, change controls, CAPAs, process capability, capacity, electronic batch records, efficiency and quality improvements.

KEY ROLE AND RESPONSIBILITIES:

Equipment Identification, Qualification, and Support

  • Work with a cross-functional team to ensure appropriate equipment selection and procurement.
  • Facilitate equipment installation, commissioning, and qualification.
  • Provide technical support of equipment during the onboarding phase and during ongoing operations.

Product, Process, and Technology Transfers and Changes

  • Execute transfers of new products and processes to ensure smooth transition from process development into GMP manufacturing.
  • Train Manufacturing staff as necessary on new unit operations and processes being transferred.
  • Provide support for the MSAT team and cross-functional project teams in areas of facility fit, gap analysis, FMEA risk assessment, troubleshooting and investigation.
  • Train MSAT engineers responsible for technology transfers and process troubleshooting.
  • Assist in documenting changes/updates to manufacturing processes and work with cross-functional teams to implement those changes.
  • Support the development, validation, and revision of electronic batch records as needed.
  • Author and review, as necessary, sections of the regulatory documents and other communications to government authorities.

Investigations and Technical Support

  • Provide technical support for deviation management, lot disposition, batch record reviews so that technical issues stay off the critical path for reliable supply.
  • Provide real-time technical support to operations.

General Responsibilities

  • Identify opportunities to implement operational excellence and continuous improvement.
    • Maintain appropriate level of training for assigned responsibilities.
    • Identify, communicate, and help mitigate identified risks that could negatively impact the quality or delivery of patient therapies.
  • Assist with CAPA and change controls as needed.

Collaborate Effectively

  • Build strong relationships with Quality to ensure a compliant manufacturing environment.
  • Be a team player, offer assistance, and respond well to requests for help from team members.
  • Use good communication and build relationships.
  • Demonstrate technical acumen, operational understanding, and GMP compliance.
  • Support operational excellence initiatives.
  • Promote a culture of safety and GMP compliance.
  • Identify opportunities for continuous improvement.

 PREFERRED EDUCATION:

  • BA/BSc with a minimum of 6 years’ experience in support of cell culture and upstream operations for GMP biopharmaceutical manufacturing; or
  • MBA or MSc with a minimum of 4 years’ experience in support of cell culture and upstream operations for GMP biopharmaceutical manufacturing

 PREFERRED EXPERIENCE:

  • Minimum 2 years’ experience supporting cell or gene therapy manufacturing.
  • Experience in technical roles within a GMP biopharmaceutical manufacturing operation, experience working in process development is a plus.
  • Experience with manufacturing automation and MES software systems.
  • Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).

 KNOWLEDGE, SKILLS AND ABILITIES:

  • Working knowledge of USA and global regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, including requirements for clinical phase appropriate validation/qualification.
  • Strong collaboration and influencing skills, with demonstrated ability to problem solve and drive positive change.
  • Proficient in MS Office and statistical software (R, JMP or Minitab).
  • Proven ability to effectively lead projects in a fast-paced environment.
  • Excellent written and verbal communication skills.
  • Proven track record in a cGMP environment.
  • Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.
  • The desire and ability to work in a fast-paced, start-up environment.

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:

  • Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product.  A vision test may be required.  Use of corrective lenses is acceptable.
  • Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns.

 

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
 
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.  The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
 
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.
 

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