An amazing opportunity has arisen for Lead Bioprocess Associate in our new state-of-the-art manufacturing facility for commercial large-scale drug substance biotech production.
The successful candidate will be a leader with strong interpersonal, communication, and collaboration skills. They will support the manufacturing process while fostering an inclusive culture that prioritizes safety, quality, and continuous improvement.
What you will do:
1. Work with manufacturing operations and automation teams to ensure proficient operations of the biotech manufacturing facility.
2. Support the operations team in achieving key performance indicators (KPIs) such as EHS metrics, production plans, OEE, compliance, and team training.
3. Own the commercial manufacturing processes in your area, following established work instructions and SOPs.
4. Coordinate a dedicated process team, emphasizing flexibility and teamwork.
5. Assist and support maintenance, engineering, quality, or other departments as needed.
6. Manage scheduled activities within your area according to the work plan and schedule.
7. Ensure timely completion and closure of all documentation, including logbooks, electronic batch records, and protocols.
8. Promote and champion Right First-Time principles.
9. Act as the escalation point, ensuring issues are communicated per site procedures.
10. Advocate for continuous improvement initiatives.
11. Reference past experiences to determine solutions during problem-solving activities.
12. Participate in internal audits and risk assessments to ensure compliance.
13. Lead coaching and mentoring efforts for MPS system skills transfer.
Qualifications:
1. Degree in Science, Quality, or Technical field.
2. At least 6 years of experience in biopharma or a similar industry.
3. Preference for Lean Six Sigma certification.
4. Experience in a highly regulated drug substance manufacturing environment is essential.
5. Start-up experience in large-scale commercial drug substance facilities is desirable but not mandatory.
6. Excellent understanding of downstream processing.
7. Experience leading small teams within a manufacturing environment.
We are committed to 'Inventing for Life' and placing the patient at the center of our work. We value diversity and are proud to be an equal opportunity employer. For support during the recruitment process, contact the Talent Acquisition Advisor.
We offer flexible working arrangements, including a hybrid model. Please discuss your flexibility needs during your application or learn more about our hybrid working model.
If you're ready to:
Invent solutions for unmet healthcare needs, apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
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