Specialist, BTS

Job Description

Position Overview - Basic Functions & Responsibilities

• Responsible for directing technology development process development and process improvement of the Large Molecule (LM) vaccine portfolio for all species. Activities are carried out in local projects with high complexity covering the discovery pre-development and development phase as well as transfer from R&D to Manufacturing licensing and implementation .
• Independently setting up and executing a project focusing on processes for the development of new products improvement of existing products or solving problems in the production of existing products.
• Works together with Quality departments Manufacturing LM site R&D species teams Discovery & Technology Product stewards Regulatory Affairs Procurement Supply Chain and Network strategy to achieve our company AH business goals.
• Fulfilling research project management skills research design reporting and presenting project (progress) reports.
• Interacting closely with fellow scientists within and other departments

Primary Activities (Technical & General)

Leads or co-leads at least a minimum of 2 projects at any given time including the pre-development pilot scale-up transfer & commercialization and provides technical support on the site.

• Is responsible for independent planning and executing a project/experiment. Can provide coordinating and substantive guidance on projects.
• Ensure regular adequate and complete reporting of the research carried out.
• Drives research on all used platform technology (e.g. bioreactor technology RB egg-based RP and Perfusion formulations emulsion and Freeze-drying technology etc.). This comprises the development of serum-free media in vitro test development improved downstream processes new hardware for USP and DSP single-use component technology etc.
• Executes and owns regulatory documents such as study reports OOP batch records SOPs and MMIs for new drug applications production departments and Quality.
• Leads or members of transfer teams responsible for the transfer of production processes from site to site and R&D to Manufacturing.
• Conducts literature study in connection with current or future projects.
• Communication and exchange of know-how between global BTS departments and Global R&D and Manufacturing to benefit from synergies and optimize utilization of knowledge and technology.
• Operational responsibility for the development of improved processes (upstream and downstream) and resolving manufacturing and supply issues of our vaccine portfolio according to the needs of Manufacturing.
• Co-leads or supports major Method development projects with a high degree of independence in cooperation with R&D and Quality partners as appropriate
• Drives identification feasibility assessment and supports implementation of new technologies in cooperation with R&D and Quality partners
• Performs co-development/Single POC activities with a high degree of independence

Minimum requirements

• Masters degree or above in a relevant field (e.g. Biology Virology Veterinary sciences Biotechnology Bacteriology Bio-Engineering and Molecular biology etc.) with a minimum of 3 years of work experience in research institutes universities or the biopharmaceutical industry involving LM process development assay development method validation technology transferring etc.
• Practical knowledge and hands-on expertise regarding LM upstream process technology for biopharmaceuticals at laboratory and manufacturing scale e.g. cell/viral culture bioreactor filtration and/or purification process.
• Familiar with aseptic biopharmaceutical manufacturing process technologies including any pilot scale scale up/down Design of Experiments (DoE) and statistical analysis to support the decision-making.
• Well-versed with good documentation practice and technical writing.

Skills

• Good interpersonal collaborative and verbal/written communication skills well organized and able to work independently and make decisions in a team environment.
• Good conceptual analytical problem-solving and critical thinking skills.
• Self-motivated and value-driven.
• Quality management and GMP knowledge in the biopharmaceutical industry (preferred).
• English Language skills verbal and written (preferred).

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.