Senior Scientist, Process Development

Posted 26 Feb 2019

Carlsbad, California - United States

Req Id 188301

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your Role:

Design, execute and analyze studies related to client projects as well as internal projects. Hands-on involvement in: upstream production, midstream processing and downstream purification of viral vectors. Active participation on process characterization/validation, risk assessment, client interaction and intercompany training.

The Senior Scientist will be responsible for a wide variety of projects to generate viral vector products. The Senior Scientist will be the primary lead and scientific resource for such projects in the Process Development Department.

The Senior Scientist is responsible for understanding the scope of work, generate all related documentation (as required), perform the studies, generate data, generate product, coordinate testing with Analytical Services, analyze results and create development report. The Senior Scientist is expected to interact with client prior to initiating a program (providing technical guidance) as well as throughout the project (providing updates and troubleshooting when needed).

The Senior Scientist will also interact with Business Development and Contracting to generate the scope of work for new projects. The hired person is expected to interact with the Tech Transfer team and the Manufacturing team to facilitate the transfer of the process from Process Development into GMP Manufacturing. The Senior Scientist will be the subject matter expert for the projects/processes and will be part of the response team related to troubleshooting, process outcome assessment and recommendations/suggestions to clients. The Senior Scientist is expected to get involved in Process characterization and Process Validation studies as part of commercialization.

ESSENTIAL JOB FUNCTIONS

  • Act as the technical subject matter expert for specific defined area(s) of Process Development.
  • Act as the lead scientist on customer or internal projects.
  • Liaise closely with clients to ensure their expectations are met or exceeded. This should include input into technical design of studies and ongoing scientific support throughout these projects / programs.
  • Generate timeline and ensure timely initiation and completion of all studies – on quality, on time and within budget.
  • Review and provide technical feedback on Master Batch Records generated by the Tech Transfer team to serve as guidance for Engineering run execution as well as means for final drafts of cGMP documentation.
  • Review and provide technical feedback on Item Specifications and SOPs.
  • Participate in Process transfer and/or Process validation activities.
  • Participate in critical event / lab investigations / troubleshooting within the Site.
  • Work with operational departments within area of expertise to update production and purification processes in line with the appropriate Validation Master Plan and client / regulatory expectations.
  • Lead by example, offer scientific coaching and mentoring to other staff members (training and scientific support for ongoing projects).
  • Monitor industry trends to ensure that relevant new technologies can be assessed and evaluated. Provide updates of technical developments, new technologies, innovation within the industry to Operations teams (Process Development, Tech Transfer and Manufacturing), Support teams (analytical services as relevant), and other members of the Technical Support group.
  • Promote a culture of continuous improvement within Process Development; act as champion on initiatives and/or projects to drive improvement in client service.
  • Prepare and present (internally and externally) scientific data, abstracts, papers, posters, etc. to advance the reputation of MilliporeSigma Carlsbad within the marketplace.
  • Track and trend key production parameters and recommend courses of action to address any adverse trends and / or issues that arise.
  • Provide technical advice and support for client and regulatory interactions (audits, meetings, teleconferences and inspections).
  • May support sales in the field and attend client visits with account managers.
  • Excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc.
  • Excellent time management skills
  • Highly collaborative as well as independent
  • High level of initiative
  • May perform other related duties as required and / or assigned.

Who You Are:

Basic Qualifications:

  • Ph.D. in Cell and Molecular Biology, Virology, immunology, bioengineering or related scientific field. 
  • 5+ years of relevant experience in Cell and Molecular Biology, Virology, immunology or bioengineering
  • 5+ years hands-on experience in executing and overseeing technical projects and/or related studies (i.e. Virology, Molecular Biology, Cell Biology, etc.)
  • 3+ years of scientific recognition in specific area in the industry (i.e. viral vector production and purification).
  • 2 + years’ experience leading and/or supervising staff in a laboratory setting

Preferred Qualifications:

  • 8+ years of hands on experience set for aseptic technics in handling cell culture.
  • ­8+ years of hands on experience of various platforms used for suspension cultures and adherent cultures.
  • 6+ years of hands on experience set for large scale cell culture using bioreactors.
  • 6+ years of experience, knowledge and hands-on experience of various approaches used for downstream purification focusing on tangential flow filtration and chromatography.
  • 10 years of experience working with computer programs including but not limited to word processing, presentation software and data analysis
  • Effective coaching and training (or supervisory where relevant) skills for complex and highly technical work

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at come2emd.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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