Sr. Scientist, External Analytical Sciences

Job Description

The Global Quality- Large Molecule Analytical Sciences (GQ-LMAS) team leads the global analytical technical oversight of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support for Large Molecules (Vaccines and Biologics) and Cross-Modality Compounds (i.e. Antibody-Drug Conjugates).

This team is highly motivated fast-paced and focused on a robust analytical testing network that enables our companys strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial product. This External Analytical position will direct and manage the analytical activities within our commercial external manufacturing and testing network. This role involves developing and implementing site-related analytical strategies and site implementation of continuous improvement in analytical methods and techniques and driving successful analytical execution by the contract testing lab(s) to support on time batch release.

Additionally this position will work directly with technical operations quality regulatory microbiology and analytical program leaders on a regular basis to review/approve critical documents relating to analytics and participate as a site representative for method life-cycle related tasks.

Responsibilities include but are not limited to:

• Analytical technical oversight working directly with the external provider(s) and internal cross-functional stakeholders to support analytical testing of large molecule (biologics and/or vaccine) products.

• Position includes significant on-site presence at external testing provider(s) to support direct engagement and technical oversight of critical analytical testing activities.

• Build and maintain strong relationship with External Entities as well as internal operations technology analytical and procurement organizations. Closely collaborates with appropriate business and functional areas to conduct Tier meetings and Joint Steering Committee meetings (as applicable) to achieve our objectives.

• Collaborate with departmental and cross-functional commercial manufacturing teams to support facility start-up and sustainability activities.

• Interface with Global Analytical Working Groups and Global Method Owners/SMEs

• Drive continuous improvement initiatives to enhance the quality and robustness of external /testing through implementation of proactive tools assay data trending corrective actions and best practices.

• Identify and resolve analytical issues deviations and out-of-specification results from external testing labs through technical support of investigating and troubleshooting analytical problems to ensure the accuracy and reliability of test results.

• Lead/support complex investigations and drive resolution of analytical technical issues

• Build and manage project plans timelines and schedules to effectively meet project timelines and deliverables.

• Ensure our external testing sites are prepared for inspections from multiple agencies (i.e. FDA EMA PMDA) from an analytical technical perspective

• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) licensure and regulatory technical questions.

SKILLS REQUIRED

Minimum Education Required and Experience:

• Bachelors Degree (BA/BS) with a concentration in biology chemistry biochemistry or related science with six (6) years of relevant industry knowledge working in the field of analytical testing development transfer and/or validation; OR

• Masters Degree (MA/MS) with a concentration in biology chemistry biochemistry or related science with four (4) years of relevant industry knowledge working in the field of analytical testing development transfer and/or validation; OR

• PhD with a concentration in biology chemistry biochemistry or related science with two (2) years of relevant industry knowledge working in the field of analytical testing development transfer and/or validation.

Required Skills and Experience:

• At least 4 years working experience in a GXP laboratory environment in the area of large molecules (vaccines biologics) analytics or Cross-Modality Compounds.

• Experience in analytical product life cycle activities (development validation and /or transfer) across various large molecule analytical platforms (i.e. ELISA HPLC CE).

• Understanding biologics analytical technology such as bioassay (i.e. ELISA cell-based methods) chromatography (i.e. HPLC UPLC) and general biochemistry methods.

• Experience in the biopharmaceutical manufacturing industry such as in biologics or vaccines commercialization technical operations and/or Quality control.

• Knowledge with In-Process Controls drug substance and drug product release stability and extended characterization testing for vaccines and biologics

• Experience with regulatory requirements and guidelines according to ICH USP Ph. Eur. and JP.

• Strong organizational and project management skills to handle multiple project associated tasks simultaneously.

• Strong oral and written communication skills to effectively communicate technical information and risks to both technical and non-technical stakeholders.

Preferred Skills and Experience:

• Knowledge of deviation management and change control processes.

• Ability to analyze interpret and troubleshoot analytical data.

• Experience in method transfer method validation new product introduction and/or analytical product life cycle activities across various large molecule franchises and analytical platforms.

• Worked and interfaced with external partners (i.e. CMOs and CTLs).

• Self-motivated with a positive proactive and service-oriented mindset.

• Capability to adapt and be flexible in a fast paced cross-functional team working environment.

• Experience with laboratory data management systems (i.e. LIMS).

• Experience with software automation/digital systems (e.g. Veeva Vault MEDs IPI Spotfire).

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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