Associate Principal Scientist - North American GMP Operations, Biologics Analytical Research and Development

Job Description

We invite individuals who possess a deep passion for promoting lifesaving and life-enhancing products to join our dynamic team. Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our company's extensive range of products from candidate selection to market authorization. At our company, we proudly continue to build upon a legacy of groundbreaking innovation while steadfastly upholding the highest standards of ethics and integrity. With a diverse workforce representing a multitude of languages and cultures, we stand unified in our collective mission to deliver revolutionary medicines and products with integrity and transparency.

We are actively seeking an enthusiastic individual to join our North American GMP Operations team as an Associate Principal Scientist in Biologics Analytical Research & Development (AR&D).  In this role, the qualified candidate will be responsible for oversight of residual DNA and residual ELISA methods (e.g. HCP and ProA) including method optimization, phase-appropriate validation, early and late-stage transfers, analytical life cycle management, and release and stability testing. The successful candidate must be able to work in a fast-paced, multidisciplinary environment and will play a pivotal role supporting Biologics to advance commercialization efforts.

The incumbent will collaborate closely with various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically sound guidance at each stage of development, and effectively manage deliverables to progress the pipeline.

Qualifications

• Ph.D. in biology, biochemistry, or related field with a minimum of 3 years of relevant experience or M.S. with a minimum of 7 years relevant experience or B.S. with a minimum of 10 years of relevant experience.  

Experience and Skills

Required

• Strong background in qPCR and/or ELISA.

• Minimum of 1 year experience working in a GMP environment.

• Extensive experience with impurity related residual assay development, validation and/or release testing.

• Experience authoring and reviewing technical documents (e.g. test methods, regulatory filings sections, validation protocols and reports)

• Sound scientific understanding of Critical Quality Attributes (CQAs) and/or QbD/DOE principles.

• Exceptional organizational skills with proven ability to manage timelines and deliverables.

• Capability to pro-actively identify and communicate risks.

• Demonstrated capability of finding innovative solutions to technical issues.

• Effective communication (oral and written) skills.

• Proven leadership skills with experience with matrix management and/or peer to peer coaching.

• Ability to adjust to shifting priorities while overseeing project tasks.

• Motivated individual with an optimistic outlook.

​Preferred

• Experience with LIMS, SoftMax Pro, electronic notebook, and/or other data analytics platforms. 

• Knowledge of cGxP operation, USP, EP, ICH, and FDA guidelines.

• Deviation management and change control processes.

• Experience with method development or regulatory submissions.

• Knowledge of continuous improvement or lean six sigma methodology.

• Experience with SoftMax Pro template creation and/or software validation.

• Familiarity with compendial method verification and testing is desirable.

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible fo