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Lead Manufacturing Specialist

Bayside Solutions Palo Alto Full-Time
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Lead Manufacturing Specialist
Menlo Park, CA

We are currently looking to bring onboard a Lead Manufacturing Specialist to help support the manufacturing and commercialization of our AAV vectors.
Responsibilities (include but are not limited to):

  • Oversee the manufacturing of AAV based viral vectors encompassing the entire process from thaw to final formulation, internally and at CMOs
  • Provide hands on support for upstream and downstream manufacturing, including Person-in-Plant support
  • Provide training and ongoing coaching, discipline and recognition of staff
  • Author and review technical documentation including SOPs, batch records, tech transfer protocols, campaign summaries, and risk assessments
  • Execute production and resource schedule against operational plan
  • Ensure performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support)
  • Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
  • Complete the final review of completed manufacturing documentation per compliance standards and established timelines to support lot release,
  • Lead key investigations related to process deviations, take ownership of CAPAs,
  • Investigate and resolve problems, identifying root cause, and proposing process improvements to support GMP manufacturing
  • Interact and build relationships with outside vendors and CMO's
  • Participate in multi-functional project teams, as necessary
  • Take corrective action to bring about required changes using change control procedures


Requirements:

  • Master's degree with 6 years of industry experience or bachelor's degree w/ 8 years industry experience in a GMP environment
  • Able to build a team as well as train entry-level personnel
  • Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions
  • Sufficient knowledge of quality systems and escalation process
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Ability to adapt in a constantly evolving environment
  • Self-motivated with a strong sense of ownership in areas of responsibility
  • Previous GMP cell culture experience and protein purification is required
  • Team management experience is a plus
  • Travel - Overall travel is 25%,

 

Skills required

Problem Solving
Provide Direction
Manufacturing
Leadership
Decision Making
Inventory Control

Location

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$130K
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Lead Manufacturing Specialist
Estimated Salary: $110K
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Bayside opened its doors back in 2001, eager to change the face of the staffing industry.  For years, we watched our competitors use rigid service models that were convenient and profitable for them – whether or not they delivered the right solutions for their clients.

Bayside took a fundamentally different approach.

We broke out of the mold of traditional staffing and consulting firms, creating a company that’s flexible and nimble. One that eliminates “corporate” red tape and enables us to deliver intelligent solutions that solve real business problems.

As a result, everything we do supports building strong relationships.  We are vertically focused, only serving a few industries. We design flexible solutions that effectively address our clients’ and contractors’ needs, initiatives and goals.  We execute a relationship-based business philosophy based on our TACIT Values – the inherent principles of Trust, Accountability, Consistency, Integrity and Teamwork that guide everything we do.

Simply put, we understand the value of solid relationships – the confidence that comes with knowing you have a partner you can really trust. One that will go the extra mile to make your business or career more successful.  One that’s honest.  Ethical.  Respectful – and, yes, kind.

12 years later, we’ve evolved from a humble staffing service, to an industry-leading provider of staff augmentation and consulting services – with an executive team boasting 70 years of combined industry experience.  We’re stronger than ever, servicing every major metropolitan city in the United States.

To this day, nothing makes us happier than delivering intelligent solutions that help our clients and contractors thrive – because to us, recruiting is personal.  We’ve raised the bar in workforce solutions, and you should never accept anything less.

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