Process Development Senior Scientist 9/2/2016
JOB DESCRIPTIONAPPLY MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
SCOPE OF RESPONSIBILITY:
Design, execute and analyze studies related to client projects as well as internal projects. Hands-on involvement for upstream production downstream purification of viral vectors. Process validation. Client interaction. Inter Company training.
PURPOSE OF THE POSITION
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 a 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 and well as provide projected costing. 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 is expected to get involved in Process characterization and Process Validation studies as part of commercialization.
ESSENTIAL JOB FUNCTIONS
* Act as the technical expert for specific defined area(s) of Process Development.
* Act as the lead scientist on "new customer production" projects as well as ongoing projects as needed.
* Liaise closely with client representatives 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.
* Generate Process Development Worksheets to serve as guidance for study execution as well as means for real-time documentation.
* Participate and/or drive Process transfer and/or Process validation activities.
* Drive implementation of new technologies.
* Participate in critical event / lab investigations / troubleshooting within Process Development and liaise with Project Management to ensure the significance of events is actively communicated to clients.
* 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. Review and recommend potential technical developments to supervisor and to senior management.
* Provide regular 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.
* Interact with Manufacturing, the client and responsible parties for process validation ensuring processes are maintained in a validated state within area of expertise.
* 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.
* May perform other related duties as required and / or assigned.
· Ph.D. in scientific discipline preferred with 4 or more years of relevant experience
· MS in scientific discipline with 6 or more years relevant experience
· Relevant working knowledge and hands-on experience in area executing and overseeing technical projects and/or related studies (i.e. Virology, Molecular Biology, Cell Biology, etc.)
· Scientific recognition in specific area in the industry (i.e. viral vector production and purification).
· Experience leading and/or supervising staff in a laboratory setting
Knowledge and Skills:
· Hands-on skill set for aseptic technics in handling cell culture.
· Proficient knowledge and hands-on experience of various platforms used for suspension cultures and adherent cultures.
· Hands-on skill set for large scale cell culture using bioreactors.
· Proficient knowledge and hands-on experience of various approaches used for downstream purification focusing on tangential flow filtration and chromatography.
· 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
· Excellent skills in applicable computer programs
· Excellent coaching skills with employees, management and other stakeholders
· Effective coaching and training (or supervisory where relevant) skills for complex and highly technical work
· Comprehensive working knowledge of company commercial and financial strategies
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.