Manufacturing Science And Analytical Technology Associate I Jobs

Proactively works with senior associates, system matter experts, and management to achieve training competency in production operations

0-2 years of cGMP experience

Excellent oral and written communication skills

Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices.

Completes setup, use and cleaning (as necessary) of cGMP production equipment.

Creates and revises SOPs (standard operating procedures) and MBRs (master batch records) as appropriate

Lead the Program Management for internal Analytical method transfers and qualification activities into AS&T and out to QC labs.

Project management of external analytical method transfers and co-qualifications at external CMOs and CTLs.

Monitor and communicate method lifecycle (acquisition, transfer, qualification / validation, implementation) timelines using project management tools.

As part of the Analytical Science & Technology team, your primary responsibilities will be as follows:

Minimum education required: Bachelor’s degree in a relevant scientific discipline

Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations

Possess knowledge of, and experience with ELISA, Capillary Western, ddPCR/RT-ddPCR, and qPCR.

The ideal candidate will have experience and understanding of qualification and validation of analytical methods.

Participates in testing to support method transfer, development, qualification, product characterization, routine GMP and non-GMP analysis, etc.

Excellent technical lab skills with attention to details and the ability to assume independent ownership of protocols/experiments.

Understands GDP and GMP regulatory requirements.

Excellent verbal and written communication skills with the ability to maintain formal recording.

Product life cycle monitoring and management experience with biologic or gene therapy products is preferred.

Experience using data management systems, analysis, and reporting tools is preferred.

Excellent written and verbal communication skills with the ability to communicate effectively across a number of disciplines and experience levels.

Prior experience and / or certification in a continuous improvement methodology (e.g. Six Sigma) is preferred

Responsible for Downstream process definition, qualification, technical support for AskBio’s late stage clinical and commercial gene therapy product portfolio.

Support equipment and reagent supplier technical evaluations, risk assessments, and raw material evaluation and qualification.

Strong communication skills, including ability to present to Sr. Management and global Health Authorities in support of GMP audits

Providing leadership for commercial technical transfer projects and management of significant process changes

Building best practices and skills within the MS&T organization to execute on our pipeline and commercial portfolio

Ensure that current knowledge of developments and innovation in pharma processes, and associated disciplines is maintained within the team.

Uses knowledge of external and internal business factors to inform decisions.

Uses understanding of BMS strategic requirements to identify future talent needs and puts plans in place to address.

Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage the performance of the assigned task

Lead changes, innovation, and continuous improvements to optimize manufacturing and ensure effective capacity use while minimizing cost

Ability to identify issues, providing solutions, and forward-thinking through solid problem-solving

Excellent verbal communication, oral presentation, self-awareness, and the impact of communication and its working style on others

Medical, Dental and Vision Insurance

Company Paid Life, LTD and STD. Life Buy Up options for self and family

Support experiments to test hypotheses based on in depth knowledge of process specialty

Assist in editing and/or reviewing standard operating procedures, technical reports and qualification/validation documentation

Bachelor’s degree or equivalent in Biochemistry, Chemistry, Engineering or a closely related field with one year of experience is required

Direct experience in protein process development function such as analytical, cell culture or protein purification

Knowledge is required in the methods of one or more of these specialties

Knowledge of GMP and GLP regulations