Senior Scientist, Analytical Research and development

Title: Senior Scientist, Analytical R&D

Location:

remote type

Hybrid

locations

USA - California - South San Francisco (Gateway Blvd)

USA - California - Santa Rosa

USA - California - San Francisco

USA - California - Oakland

USA - California - Palo Alto

USA - California - California

time type

Full time

job requisition id

R392662

Job Description:

Global Quality Large Molecule Analytical Sciences (GQ- LMAS), in our Manufacturing Division, is accountable for the commercialization of large molecule, vaccines and biologics, analytical techniques from Phase III through launch and transfer to supply.  This team is highly motivated, fast-paced and focused on the rapid advancement of our Company's large molecule pipeline, plus growth of existing products.

This position will involve oversight of late-stage method development, validation, and life-cycle management of methods with a focus on both global method transfer activities and external analytical.

From a Global Quality Large Molecule Analytical Sciences (GQ-LMAS) Analytical Transfer perspective, this position includes activities such as interfacing with a global network of product manufacturing and testing sites, collaborating with product development groups within our manufacturing division and our Research Laboratories division, continuous improvement of analytical methodology, assay validation, analytical technical transfer, and Biologics License Application preparation.

From a GQ-LMAS External Analytical perspective, this position includes directing and managing 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

Analytical Transfer:

• Lead method transfers and/or validations across vaccine and biologics programs including quality risk assessments/gap analysis.

• Provide sponsorship of both in-line and pipeline analytical methods. The candidate will interface across our Company network and external partners to ensure the successful commercialization of assays promoting our pipeline programs

• Involvement in development, troubleshooting and optimization of analytical methods

• Continuous improvement using laboratory standardization, lean laboratory, and six sigma methodology

• Assay Life Cycle activities across various large molecule franchises and analytical platforms

• Promote various vaccine and/or biologics registrations, launches, and troubleshooting activities  external to the US, including documentation preparation

• Direct strategic initiatives within departmental and cross-functional teams representing Global Quality Large Molecule Analytical Sciences (GQ- LMAS).

• Manage global registration and test on importation (TOI) activities

• Collaborating with commercial manufacturing teams to support facility start-up activities, New Product Introduction and provide analytical support both within our Company network and at contract manufacturing organizations (CMOs) or contract testing laboratories

External Analytical:

• 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.

Education

• Bachelor’s degree in biology, chemistry, biochemistry, or related science with six (6) years of relevant industry knowledge in systematic development, validation, and/or quality control (QC) or

• Master’s degree in biology, chemistry, biochemistry, or related science with four ( 4) years of relevant industry knowledge in systematic development, validation, and/or quality control (QC) or

• PhD in biology, chemistry, biochemistry, or related science with one (1) year of relevant industry knowledge in systematic development, validation, and/or quality control (QC)

Knowledge | Skills

• Knowledge of ICH, USP and other compendial chapters required for method transfer and validation.

• Knowledge with late-stage method development, validation, and transfer

• Experience with management of contract manufacturing organizations

• Minimum two (2) years working knowledge in a current Good Manufacturing Practices (cGMP)  laboratory environment in large molecules (vaccines, biologics)

• 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.

• Development and management of project timelines and deliverables

• Participation in cross-functional project teams

• Authoring and review of technical documents

• Ability to work objectively and within a cross-functional team

• Ability to learn new techniques

• Technical, verbal, and written communications, stakeholder management, and teamwork skills

• Self-motivated with a positive attitude and proven performance record

• Knowledge with drug substance and drug product release, stability, and extended characterization testing for vaccines and biologics

• Strong organizational and project management skills

• Ability to effectively identify and express risks

​ Preferred

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

• Deviation management and change control processes

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

• Ability to analyze, interpret, and troubleshoot analytical data.

• Global launch or supply experiences

• Supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA)

• Continuous improvement or lean six sigma methodology

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

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

VETJOBS

Required Skills:

• Adaptability, Adaptability, Analytical Method Development, Assay, Assay Development, Bioanalytical Analysis, Biochemical Assays, Biochemistry, Biologics License Application (BLA), Biopharmaceutical Industry, Cell-Based Assays, Chemistry, Chromatographic Techniques, Chromatography, GMP Environments, Immunochemistry, Innovative Thinking, Investigation Procedures, New Product Development, Nuclear Magnetic Resonance (NMR) Analysis, Process Analytical Technology (PAT), Project Management, Risk Assessments, Six Sigma, Strategic Thinking {+ 1 more}

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

U.S. Hybrid Work Model

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 presence.This 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

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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. 

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

 

Shift:

Not Indicated

 

Valid Driving License:

No

 

Hazardous Material(s):

n/a