TriLink Biotechnologies is seeking a Manufacturing Manager as part of the Leadership team at TriLink Biotechnologies, this individual will lead a growing functional area. Focus of the role will include owning capacity, productivity and continuous improvement efforts to meet long term growth and profitability targets. The role will work closely with other Manufacturing Areas, Quality, Planning and R&D, to develop, improve, and sustain production.
- Review and approve manufacturing data and batch records.
- Plan and manage capacity (Equipment and Labor) to meet yearly demand.
- Execute, Change Orders, Deviations CAPA's and NCMR's.
- Collaborate with development teams to lead improvement projects.
- Develop tools and reports to trend and monitor manufacturing operations process health (Quality, rework, OTD) to provide and drive actionable information.
- Hire and retain key talent to meet strategic and tactical goals and KPI's.
- Maintains safe and clean work environment by following current good manufacturing practices (cGMP), 5S and standard operating procedures.
- A Bachelorís of Science in a scientific field, preferably in Chemistry or Biochemistry with 7+ years industry experience and 3+ years supervisory experience leading teams.
- Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus.
- Experience with enterprise systems such as MES/JDE etc.
- Strong multitasking abilities to complete activities in a fast-paced, deadline-driven environment.
- Results driven self-starter.
- Strong problem-solving skills and analytical skills applied to investigations.
- Self-motivated and able to organize and prioritize multiple tasks.
- Ability to manage stress and balance competing demands in a high throughput environment.
TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.
TriLink is an EEO Employer.