CMC Project Manager
- Experience Level
Role: CMC Project Manager
Location: Oxford (homeworking offered/fully remote options considered)
Salary: Competitive + benefits
employment: full time, permanent
CPL Life Sciences are collaborating with a growing biotechnology company based in Oxford that develops vaccines and immunotherapies for infectious diseases and cancer. Our client is looking for someone with a strong CMC technical background with Biologics or Virology experience. You will support the manufacturing of their vaccine and therapeutic products and actively engage with contract manufacturing organizations, contract test labs, and their R&D scientists.
Works with the project teams to ensure that contractors fulfill contract requirements and complete process development or manufacturing projects as appropriate.
Tracks the progress of projects.
Facilitates information flow/exchange among our clients departments and between contractors.
Manage scope change in project execution.
Participates in regular internal project meetings to discuss and plan projects.
Participates in regular meetings with contract organizations to update the progress via teleconference or site visits as appropriate.
Supports records to document all relevant communications related to projects.
Monitor timelines and contracts for accuracy and follows up on any discrepancies with contractors and/or internal personnel.
Train team members as appropriate.
Supports CMC activities tracks and maintains manufacturing documentation.
Coordinates the transfer of data and records from contract manufacturing organizations.
Personal Abilities and Traits:
Demonstrates personal drive and goal orientation.
Self-motivated taking personal pride in delivering on personal and corporate objectives.
Enthusiastic and flexible to change.
Demonstrates organizational and prioritization skills to manage a diverse workload.
Able to interact with individuals at all levels of the organization.
Good communicator, both orally and in writing with an eye for detail/ accuracy.
The essential knowledge, experience, and skills:
Eligible to work in the UK
BSc or equivalent experience in science/technical.
Minimum 3 years experience of biologics, preferably viral vector manufacturing to GMP.
Understanding of CMC requirements for all phases of clinical development.
Excellent writing and communication skills in fluent English; ability to understand and communicate scientific information.
Proven ability to communicate in a clear and concise manner.
Ability to work independently, cross-functionally and collaboratively in a team.
Cover all other project management requirements including logistics and detailed project plans.
Comfort in synthesizing and understanding large quantities of data and information.
Occasional travel will be required.
Networking, both internally and externally.
Competency in Microsoft suite applications including Word, Excel, PowerPoint, and MS Project.
Experience in virology and/or Infectious Disease studies.
Working with external CMOs and experts in the delivery of projects.
Commercial awareness, interpersonal, and negotiating skills.
If you would like to apply for this position, please contact Amani via email@example.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*