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Contact: McMullin, Hugh (Hugh.McMullin@codexis.com)

Upstream Process Development Scientist

Upstream Process Development Scientist

At Codexis, we are creating sustainable chemicals, pharmaceutical processes, and renewable ingredients that make industry more efficient, productive and profitable. Industrial biotechnology from Codexis reengineers enzymes and microorganisms – nature’s catalysts – and puts them to work to solve real global challenges for the world’s largest companies.

Position Description:  

The Upstream Process Development Scientist will be responsible for the development of recombinant protein production processes and to successfully oversee the transfer of these processes to contract manufacturers. The ideal candidate will have experience with the optimization of enzyme production in microbial expression systems. This position offers the opportunity to work in a multidisciplinary team in a challenging and dynamic environment.

Responsibilities:

The Process Development Scientist will be responsible for:

  • Development of fermentation and downstream recovery processes for recombinant proteins including enzymes expressed in microbial hosts.
  • Development of fermentation processes using scale down models to predict process performance at manufacturing scale.
  • Development of unit operations at the bench and pilot-scale (10-500L) such as, centrifugation homogenization, micro filtration, ultra filtration and depth filtration.
  • Leading process development, optimization, characterization, scale-up and tech transfer to contract manufacturing.
  • Providing troubleshooting support to commercial manufacturing operations.
  • Participating in strain, process, and cost efficiency improvement efforts.
  • Must be able to lead multidisciplinary team, design project experiments and overall direction, and be able to communicate results and challenges to key stakeholders.
  • Demonstrated supervisory experience.
  • Meeting timelines for multiple projects that may be at different stages of development.
  • Identifying and evaluating new technologies for fermentation and recovery processes.
  • Authoring equipment and process SOPs and Process Safety Reviews.

Critical Competencies:

  • Strong knowledge of microbial systems, physiology and cellular metabolism, coupled with practical knowledge of process engineering and plant operations
  • Strong technical background and direct hands-on experience with fermentation processes and downstream processing unit operations such as , centrifugation, homogenization, ultra filtration, sterile filtration, lyophilization etc.
  • Sound understanding of basic protein biochemistry, microbiology, and recombinant protein expression in microbial hosts.
  • Experience in enzyme activity, protein characterization, and protein determination.
  • Experimental design and data analysis capabilities including Design of Experiments (DOE).
  • Understanding of engineering issues involved in scale up and possesses both practical and analytical skills to implement relevant scale down models.
  • Experience with lyophilization is a plus.
  • Ability to prioritize responsibilities, multi-task and remain flexible with changing needs.
  • Must be motivated and able to work under tight deadlines.
  • Excellent interpersonal and communication (oral and written) skills, documentation, organization, good record keeping, writing reports and SOPs.
  • Able to work effectively in cross functional teams to solve manufacturing problems or implement improved procedures.
  • Mentor and supervise staff as well as work effectively with management teams. 
  • Some travel to  manufacturing sites will be required

Education/Experience:

Ph.D. in Chemical Engineering, Microbiology, Microbial Physiology, or related discipline with 3-5 years of relevant industrial experience; or B.S. with at least 10 years relevant industrial experience.

The position comes with a competitive compensation and benefits package, including paid company holidays, paid time off, health benefits, 401k match, and much more.  For more information about our plans for the future, and to be considered for this career opportunity, please visit www.codexis.com.

EOE

PRINCIPALS ONLY

NO AGENCIES OR THIRD PARTIES

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Senior EHS Process Safety Manager, Site Services

Genentech

Location: South San Francisco, CA, USA

Type: Full time

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This position is part of Genentech’s EHS function.  EHS plays an essential role in protecting Genentech’s right to operate and serving as a steward for the Genentech culture embracing prevention and problem solving to reduce risks and protect our people, environment and pipeline on our SSF campus and network of places, including field employees.  At Genentech, compliance is a shared responsibility with the business.

The Senior EHS Program Manager is responsible for managing a portfolio of complex programs.  This position has overall responsibility for regulatory compliance and serves as the subject matter expert (SME) for their portfolio of programs. This position will work closely within and outside of EHS to ensure their portfolio of programs are integrated effectively into business operations.

Your work may support client groups beyond your reporting structure.  You can expect to take direction from multiple leaders within EHS who represent the needs of the client as it relates to your programs.

In representing EHS, this individual must bring a generalist level of expertise across EHS disciplines.

Job Duties/Responsibilities: 

  • Accountable for the effectiveness of their portfolio of EHS programs across the SSF site. Partners with EHS Business Partners (BPs) and EHS Specialists to develop and implement programs and strategies for the different business functions across the SSF Site.

  • At this time, the job duties for this position include: 

    • Process Safety Management

    • Asphyxiating Gas Safety

    • Pressure Vessel Safety and Hot Tap

    • Safety Showers and Eyewashes

  • Works collaboratively with stakeholders to develop practical strategies to ensure successful implementation of programs that align with business objectives.  

  • Serves as a subject matter expert for assigned EHS programs, providing related guidance and support to client groups and other stakeholders.  Works with cross-functional teams to effectively and efficiently implement programs across diverse work-groups and organizations.  Assures compliance with regulations, corporate requirements, and local program requirements.  

  • Assists with internal and external audits and inspections relative to assigned programs, including reporting, notification, facilitating regulatory inspections, and ensuring closure of corrective actions.

  • Represents EHS as a primary contact for key stakeholders on initiatives and projects related to their EHS programs.

  • Delegates routine programmatic tasks to EHS Specialists to support the ongoing success of EHS program implementation across all business units.  EHS Specialist resources will be shared by several Program Managers and Business Partners.

  • Coaches and/or mentors EHS Specialists, EHS Business Partners or other Program Managers in their programs and/or areas of expertise.

  • Participates in and supports business process improvement initiatives to drive improvement within the EHS function and the client’s function.  

  • Serves as needed as a Safety Officer during disaster/emergency response and recovery efforts. May also be required to serve as EHS Advisor (technical expert) for the emergency response team during company-related emergencies.

Competencies Identified for Success: 

  • Working knowledge of environment, health and safety regulations, codes and standards, including OSHA, EPA, DOT, NIOSH, FDA and other regulatory requirements applicable to GMP and non-GMP environments.

  • Highly effective team player and collaborator. Strong comfort working in a matrix and agile environment where expertise is leveraged across functions.

  • Effective at reframing challenges into opportunities.  Track record of being resilient and adaptable in navigating organizational resistance and influencing others to adopt new behaviors and approaches.  Champion for EHS.

  • Listens deeply to key stakeholders, and considers their needs along with regulatory requirements and best practices to make informed decisions.

  • Strong analytical and problem-solving skills.  Able to manage multiple programs and develop solutions to complex problems.

  • Exercises independent judgment in selecting methods, techniques and evaluation criteria for obtaining exceptional results to a variety of complex problems. Performs work with limited direction. 

  • Expertise in multiple EHS disciplines with demonstrated examples of being innovative and agile in adapting to changes within and across different business functions.

  • Excellent teamwork and collaboration skills. Able to facilitate and lead cross-functional and interdepartmental teams in a fast-paced and diverse environment.  This may include leading agile teams focused on creating value for the business.

  • Strong communication skills, comfortable leading meetings and delivering effective training. Able to present information in a way that is simple and easy to understand by the targeted audience(s) that could include individual contributors to Directors.

Qualifications: Education, Experience, Knowledge and Skills: (Minimum requirements)

  • Education:  BA/BS in occupational safety, environmental/health sciences, engineering or other applicable field of study.

  • 8+ years of relevant work experience, preferably in pharmaceutical, biotech, medical device, chemical or high tech industries.

  • Certification in one or more of the following areas is strongly preferred: Certified Safety Professional (CSP), Certified Safety Manager (CSM), , and/or Project Management Professional (PMP).

  • Experience operating successfully in a matrixed organizational structure and leveraging expertise across functions.

  • Practical experience with Lean/Six Sigma (or other business process improvement methodologies), including a belt certification, is desirable.

  • This position is not eligible for relocation.