The Supervisor, Oligonucleotide Synthesis position is responsible for overseeing the synthesis of oligonucleotide production for Cepheid's in-vitro diagnostic products. The position should have a high level understanding of chemistry and oligonucleotide chemistry in particular. The position will also heavily involve scheduling/planning activities as well as continued improvement and implementation of new processes and products. Responsibilities include but are not limited to: overseeing routine production; raw material and resource scheduling, batch record review; authoring technical reports including validation and qualification plans; process validation for projects moving from development into manufacturing; scale-up and improvement of existing procedures; selection, implementation and maintenance of equipment, and preparation of plans, reports and process procedures. The position works closely with the Planning and Procurement team, Research & Development team, Facilities/EHS team, and Quality Systems when needed.ESSENTIAL JOB RESPONSIBILITIES:
- Manage daily manufacturing of production lab, planning, and resource scheduling for synthesis.
- Prioritization of production work based on deadlines and work flow, and delegation of tasks to other production associates.
- Responsible for automated synthesis equipment and HPLC purification systems.
- Validation of new equipment, methods and processes from the Development team.
- Improvement of current manufacturing procedures, including new scale-up synthesis and purification methods.
- Ability to identify, initiate, execute, and complete projects to improve workflow and reduce bottlenecks.
- Ability to multitask and perform project prioritization to accomplish goals in a dynamic fast past environment.
- Ability to work with different groups, managers, make decisions, and direct workflow of other associates.
- Creating and revising production documents in a controlled and regulated environment.
- Ensure and adhere to GMP compliance and maintain a clean/ traceable work environment.
- Ability to coach or mentor other associates and help lead an efficient team.
- BS degree with a minimum of 5 years industry experience,
- or MS degree with a minimum 3 years' experience in a chemistry
- or PhD and 1 year minimum biochemistry position equivalent combination of education and experience to perform at this level.
- Ability to work in an office and chemical laboratory environment.
Knowledge and skills:
- General knowledge of the oligonucleotide chemistry and equipment is a plus.
- Leadership experience
- Lean manufacturing experience or knowledge
- Working knowledge of automated oligonucleotide synthesis, purification systems, automated instruments, and analytical equipment such as UV, HPLC and LCMS would be a plus.
- Experience in a regulated manufacturing environment (ISO or GMP) and working knowledge of QMS and regulations.
- Ability to take initiative on projects, creatively solve problems, and is highly organized.
- Excellent written and verbal communication skills.
- Able to work independently and in a strong team environment to achieve shared group goals.
When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System
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