A pharmaceutical company in Fremont, CA is seeking a Scientist I to join their team!
The Scientist I will actively contribute to the manufacturing and technology transfer projects. As part of the Purification/Manufacturing group, you will have opportunities to work on and take ownership of a wide-ranging set of projects for troubleshooting and investigations, system and work flow implementation, facility build out, and tech transfers of processes into the GMP manufacturing facility. The position performs professional planning, coordination, analysis and reporting of various project work according to company guidelines and project management strategies. The role will frequently provide hands-on execution of complex experiments in a team setting. The position will train, supervise, and mentor technical staff with opportunities for growth into management.
The role will support GMP readiness and manufacturing activities.
Scientist I Essential Duties and Responsibilities:
- Executes and supervise complex unit operations including but not limited to chromatography, TFF, depth filtration and virus filtration.
- Maintains own training within compliance and trains other associates on protein purification in GMP environment upon completion of trainer qualification.
- Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP downstream manufacturing activities.
- Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established by site.
- Maintain cleanroom standards, practices, and housekeeping according to SOPs.
- Recognize any issues from the equipment and any affiliated documentation and take appropriate corrective action within scope. Notify managers and leads of issues and discrepancies immediately.
- Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
- Evaluate new technologies and innovations to improve operational efficiency or expand purification capabilities
- Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.
- Present during inspections from regulatory agencies and client audits
Scientist I Qualifications:
- BS, or MS in Engineering, Life Sciences, or related discipline with 3+ years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
- In-depth understanding of protein chemistry and industry-standard purification processes (affinity, IEX, SEC, viral inactivation and filtration, depth filtration, UFDF, etc) and equipment (GE AKTAs, disposables)
- Hands-on experience in running, developing, and validating processes.
- Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
- Experience with process monitoring software and equipment software (UNICORN, Pi Historian).
- Creative thinker that can identify better and more efficient methods to address issues and gaps.
- Demonstrate ability to work independently and on cross-functional teams.
- Strong analytical skills and attention to detail.
- Effective verbal and written communication skills.
- Flexible mindset for a dynamic environment.
- Ability to independently evaluate technical situations and propose potential solutions.
- Must be able to work independently as well as work with a diverse team.
- Ability to prioritize assignments and to manage multiple projects simultaneously.
- Capable of independent and rapid decision making based on data, scientific knowledge, and sound judgement
- Must have the ability to work efficiently in a fast-paced environment.
- Flexibility with work hours to meet business needs, including weekends and holidays, as needed.
- Management experience is a plus
- Must be legally authorized to work in the United States without restriction.
- Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.