Team Lead Process and Analytical Development

Posted 26 Nov 2018

St. Louis, Missouri - United States

Req Id 181155

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

The ideal candidate will develop and implement analytical control strategies for complex biological and bio-organic custom projects. The role will also involve transfer of analytical methodologies to GMP quality control groups. The team lead will lead, train and develop a small team and will be responsible for customer interactions. He/ she will be part of an expert team focused on delivering new insights and technologies in the pharmaceutical and/or specialty chemical industries.

Essential position responsibilities

Deliver required analytical data for routine analyses, and method development and optimization to enable efficient process and analytical development.

Lead analytical project efforts, deliver project milestones on-time and on-quality, and represent analytical on cross-functional project core teams with representatives from Project Management, Process / BioProcess Chemistry, Engineering, Manufacturing, QC, and QA.

Qualify and evaluate analytical methods for the transfer to cGMP Quality Control laboratories for method validation.

Master the technical and theoretical aspects of new analytical techniques and contribute to critical path needs of various project development teams.

Consistently demonstrate attention to detail in the planning, execution and documentation of experimental work.

Deliver timely and comprehensive written (laboratory notebooks, SOPs, and development and qualification protocols / reports) and oral communications to both internal and external stakeholders.

Continually enhances the skill level of his/her organization by investing in the development and learning of the organization’s employees, and by actively participating in the selection of external tale

Promotes a climate of positive employee relations by fostering two-way communication and by resolving employee issues in a timely manner.

Who You Are

Basic Qualifications:

  • Ph.D. in a Scientific Discipline with 3-4 years of academic, or industrial experience, prior supervisory experience highly preferred.
  • Masters in a Scientific Discipline with 6 years of industrial experience with prior supervisory experience will be considered.
  • Bachelors in a Scientific Discipline with 8 years of industrial experience with prior supervisory experience will be considered.

Preferred Qualifications:

  • Knowledge and demonstrated skills in bioanalytical chemistry, biophysical chemistry, biochemistry, protein chemistry and/or molecular biology highly preferred.
  • Well-organized and detail oriented, able to effectively prioritize, interact cooperatively and effectively with others in a matrix organization and consistently demonstrate reliability, responsibility and independence..

    Essential and Critical Skills

  • Proven ability to lead a team in technical excellence, project completion and people development.
  • Demonstrated skills in general and advanced laboratory techniques (theory and practice) to enable the development of novel approaches to solve complex analytical problems on fast-paced projects with changing priorities.
  • Current knowledge of small molecule or bio-therapeutics drug development process. Experience with antibody-drug conjugation is a plus.
  • A genuine desire to translate new science into new therapeutic technologies and the ambition to succeed in an innovation driven environment.
  • Demonstrated success in contributing to the advancement of projects, project teams, and process improvements.
  • Well-versed in regulatory requirements to assure appropriate design and execution of drug development and manufacture.
  • Extensive hands-on experience and in-depth knowledge of 5 or more of the following bio/analytical technologies including: chromatography (HPLC/GC/IC/UPLC/LC-MS/GC-MS/SEC/HILIC/), electrophoresis (capillary CGE or iCE and traditional gel techniques), SDS-PAGE, immunoassays (ELISA, western blot, and dot blot), enzyme kinetics, and plate-based biochemical assays, absorption spectroscopy, slope spectroscopy, protein characterization, protein functional assays, FTIR, NMR, wet chemistry and/or USP methodologies.
  • Excellent time management, attention to detail and strong communication skills (both written and verbal). Customer-facing experience is vital.
  • Champion new analytical technologies that can be applied to process and drug development. Propose strategy and manage development, qualification, documentation, and transfer of assays.
  • Automation (medium to high-throughput) experience in an analytical setting and instrument maintenance / troubleshooting highly desirable.
  • Working knowledge of Microsoft Word, Excel, and PowerPoint, as well as experience with advanced data acquisition and/or statistical software systems.
  •  As part of a multidisciplinary team, the candidate should be able to efficiently communicate concepts to both specialist and general audiences.
  • Ability to coordinate information exchange and manage data generated by contract testing labs.
  • Comply with SAFC safety policies, practices and SSOP

EMDRSR


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.

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