Senior Scientist, Analytical Research and Development

Job Description

North American GMP Operations Rahway NJ

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 Companys 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 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 seeking an enthusiastic Senior Scientist (R3) to join our Rahway NJ team in Biologics AR&D GMP Operations. The role involves developing and performing analytical methods for raw materials testing authoring and maintaining Standard Operating Procedures (SOPs) supporting instrument qualification and collaborating with production for timely compliant raw material release for clinical batch production. Candidates should thrive in a fast-paced multidisciplinary setting and will play a key part in advancing Biologics commercialization.

The incumbent will work with stakeholders such as Technical Operations Manufacturing Analytical Development Large Molecule Assay Validation Quality Assurance and CMC Regulatory Affairs to solve technical issues offer scientific guidance throughout development and manage deliverables to advance the pipeline.

Responsibilities

• Execute activities in accordance with Good Manufacturing Practices (GMP).

• Author review and maintain Standard Operating Procedures for raw materials testing instrument operation and laboratory processes.

• Support instrument qualification (IQ/OQ/PQ) activities for analytical equipment.

• Implement traditional and advanced analytical methods to support execution of raw material testing.

• Serve as an SME for raw materials analytical testing procedures and practices at our Biologics Development Center in Rahway and North Wales PA labs.

• Oversee project timelines and deliverables focusing on coordinating raw materials testing to meet clinical program this role work closely with the production team process development and analytical development staff to understand manufacturing schedules and ensure prompt analytical support is provided.

• Support the development and improvement of raw material workflows for existing and newly constructed manufacturing facilities in our network.

• Supportbiologicsregistrationsproductlaunches and troubleshooting activities.

• Support compliance audits inspection activities and investigation/CAPAs.

• Advance strategic initiatives across matrixed teams.

• Author and review technical documentation including regulatory submissions.

• Additionalresponsibilities as assigned to support the evolving needs of the department.

Qualifications

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

Experience and Skills

Required

• Knowledge of chemical properties and traits of common biologics manufacturing materials including salts excipients media components and chromatography resins.

• Proficient in analytical techniques including spectroscopy (such as FTIR and RAMAN) UV spectrophotometry and compendial methods like pH and conductivity testing.

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

• Able to proactively recognize and communicate potential risks.

• Proven ability to solve technical problems with innovation.

• Ability to work independently and within amatrixedteam.

• Effective communication (oral and written) and leadership skills.

• Stronginterpersonal skillswithadeptness tolead byinfluencing others.

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

• Willingnessto occasionally work irregular hours including evenings and weekends as needed.

• Occasional travel to our Pennsylvania laboratory as required.

Preferred

• GMP experience and understanding of data integrity principles (ALCOA) for documentation are highly preferred.

• Experience and understanding of testing raw materials in pharmaceutical or similar settings.

• Skilled in LIMS Empower electronic notebooks and data analytics platforms.

• Knowledge ofcGxPoperation USP EP ICH and FDA guidelines.

• Experience with analytical method validation and life cycle management.

• Deviation management and change control processes.

• Experience with method development and/or regulatory submissions.

• Continuous improvement or lean six sigmamethodology

Required Skills:

Preferred Skills:

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As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

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The salary range for this role is

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 employees 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. 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.

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

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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.

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