Scientist, QC Technical Transfer Lead Full-time

Scientist, QC Technical Transfer Lead

BMS Cruiserath Biologics is seeking to recruit a Scientist, Technical Transfer Lead for the QC Shared Services Team. The technical transfer lead will be responsible for supporting insourcing of new products into laboratories as per agreed timelines to support the Cruiserath Biologics SDP and MPCC manufacturing schedule or support of testing for products manufactured within the BMS network.

Key Duties and Responsibilities:

• Project management and co-ordination of QC technical transfers for new products to the QC laboratories, inclusive of raw material, cleaning validation, in process, DS and DP methods for SDP, GBL and MPCC.
• Ownership of QC change controls for new product introductions.
• Maintain oversight of all ongoing transfers to the QC department and ensure adherence to agreed timelines.
• Provide escalations where required and facilitate/drive resolution across relevant teams.
• Definition of Transfer Strategy for new products to the QC laboratories.
• Support resource management for tech transfer insourcing across QC teams.
• Point of Contact for QC Technical Transfer at cross-functional meetings.
• Ensure Laboratory Readiness across QC departments to support testing.
• Support tech transfer standardisation and process improvements as required.
• Compliance with Standard Operating Procedures and Registered Specifications.
• Ensure the laboratory is operated in a safe manner and a Safety culture is embedded within the team.
• Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
• Approval of SOPs, trend data, non-conformances, Transfer plans, validation protocols, reports, method verifications and equipment qualifications where required.
• Participate in regulatory agency inspections as required.
• Strategically plan and implement procedures and systems to maximise operating efficiency through the use of Operational Excellence tools.

Qualifications, Knowledge and Skills Required:

• A minimum of a B.Sc. in Biochemistry or related discipline and must have at least 5 years' experience, in a GMP laboratory setting with QC testing.
• Understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories is desirable, strong background in and aseptic manufacturing is an advantage.
• Demonstrate leadership ability and flexibility along with good communication and teamwork skills. Excellent communication skills are critical. Ability to communicate on a global level is required, in addition to meeting management skills.
• Excellent organisational and planning skills.
• Demonstrated experience in corporate and regulatory audits

Why you should apply:

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ “, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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