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: The Senior Associate Scientist will perform safety testing required to manufacture clinical and commercial products; perform assays/ testing for a laboratory within Biologics. This position may have supervisory responsibilities for associate scientists I and II. The Senior Associate Scientist is required to make scientific observations, maintain detailed workbooks/ documentation and ensure all documentation fulfills generally accepted professional/industry standards. Requirements also include maintaining a thorough understanding of BioReliance services, technical principles and applications.
ESSENTIAL JOB FUNCTIONS
- Act as subject matter expert (SME) for specific defined area(s) of BioReliance business.
- Applies laboratory techniques and skills to complete experiments designed to address a variety of specific problems.
- Independently applies basic scientific principles in the design of experiments and the development of assays.
- Performs testing in accordance with SOPs and regulations (cGMP and GLP) for custom/ non-routine and new services.
- Maintains complete and comprehensive records for study integrity.
- Makes detailed observations, documents results and performs data analysis.
- Operates and maintains lab equipment as required by SOPs and testing procedures.
- Utilizes applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc.).
- Utilizes problem solving/ trouble shooting skills.
- Communicates deviations/ events, progress and interim results to Study Management.
- Leads the completion of event records.
- Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing.
- Maintains a working knowledge of lab procedures and assays.
- Creates/ revises SOPs, laboratory records and other related documentation as assigned.
- Writes technical reports for internal use and collaborates on papers for external use.
- Performs training of laboratory personnel as needed/ assigned
- May serve as team lead.
- Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment.
- Acts as key driver/ champion on project teams.
- Complies with company health and safety regulations and procedures.
Who You Are
Education (minimum requirements):
- Ph.D. with a focus in Virology
- Experience with method and assay development and validation process
- Prefer at least 1 year of GxP experience in FDA regulated environment
- Strong documentation and communication skills
- Experience with cell line management and cell culturing for viruses is strongly preferred
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil 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.