Biologics - Assistant Scientist-Lab Manager

ssistant Scientist--Lab Manager
New Brunswick and Summit West Locations
This role is 100% Onsite

PURPOSE AND SCOPE OF POSITION: Assistant QC Scientist is responsible for supporting lab management related activities within the New Brunswick (primary) and Summit (secondary) Biologics Development (Client) methods development department in direct support of clinical method development activities. This includes the ability to interface with cross functional groups and independently perform tasks. This individual will focus on the timely and quality ordering, receipt, storage of lab supplies, inventory tracking, lab instrumentation maintenance including freezers, pH meters, balances, pipettes, HPLC, UPLC, and Capillary Electrophoresis (CE) systems. Opportunities to provide general assay support and development. Additionally, the assistant QC Chemist will be responsible for continuous improvement of the lab management processes from the New Brunswick and Summit West methods development laboratories.

REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
• Working experience in research laboratory environment.
• Ability to keep accurate records, strong attention to details, follow instructions, and comply with company policies. • Advanced ability to accurately understand, follow, interpret, and apply Global GMP requirements.
• Advanced ability to communicate effectively with team members, department management and cross-functional peers.
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Good interpersonal skills are a must.

Technical writing skills:
• Problem-solving ability/mentality, technically adept and logical.
• Knowledge of HPLC, UPLC, and CE instrumentation a plus.
• Ability to set priorities, manage timelines and effectively react/manage changing priorities.
• Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers.
• Ability to utilize electronic Quality systems, Word, Excel, and PowerPoint.

Education and Experience:
• Requires a bachelor's degree in science, preferably in Biochemistry, Chemistry, Molecular and Cellular Biology, or related discipline.
• 4- 7 years of relevant work experience, preferably in a health authority regulated environment. • An equivalent combination of education and experience may substitute.

It is preferred that the candidate have analytical experience including but not limited to in the following techniques: •Chromatography (HPLC or UPLC),
•Spectrophotometry (UV/VIS),
•Capillary Electrophoresis (CE) based testing.

DUTIES AND RESPONSIBILITIES:
Attached is the completed Contingent Worker FSP Playbook in word format. However, approval attachments can't be sent in MS Word since they were responses sent by emails, but I have attached each Finance, HRBP and Procurement approvals separately.

The successful candidate will perform key activities including:
•Inventory management
•Ensuring laboratory cGMP compliance is maintained
•Execution of UPLC and HPLC instrumentation maintenance (cleaning), assisting with laboratory work orders
•Writing procedures and technical documents as required
•Pipette calibration organization,
•Providing communication of business-critical information to methods development management
•Perform general HPLC/UPLC/CE methods as needed.
•This is a laboratory position at the New Brunswick, NJ and Summit NJ locations.