Associate Principal Scientist, Regulatory CMC, Synthetic Moities of ADCs & Bioconjugates

Associate Principal Scientist Regulatory Cmc - Biologics (R4)-Synthetic Moieties (Drug-Linker) Of Adcs And Bioconjugates

This Associate Principal Scientist position is equivalent to an Associate Director position.

Under direction from Director/Executive Director, the R4 Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's Antibody drug conjugates (ADC) and other biologics conjugate product franchises in accordance with domestic and international regulations and guidance.

Position responsibilities include but are not limited to:

• Serve as a Regulatory CMC Lead for the Synthetic-Moiety (Drug-Linker) of assigned antibody-drug conjugate (ADC) and other bio-conjugate programs, providing regulatory leadership within Regulatory and on cross-functional teams. Be accountable for the delivery of all regulatory milestones through product development and post approval life cycle.
• Develop and execute robust, phase-appropriate global Regulatory CMC strategies for drug-linkers, payloads, linkers, peptides, and other chemically synthesized moieties that are part of bio-conjugate molecules.
• Be accountable for the execution of global product regulatory strategies by robust assessment of global regulatory CMC requirements and identification of potential risks.
• Integrate the regulatory strategy for synthetic moieties with those for the targeting component, conjugation process, conjugated drug substance, and drug product, including alignment of dossier content, data requirements, and regulatory milestones.
• Manage preparation and execution of CMC documentation including IND/IMPD original BLA/MAA, or Post approval / variations, agency meeting background packages and responses to health authority questions per established business processes and systems.
• Manages change controls and develop regulatory filing strategies with an understanding of regulations and company policies and procedures.
• Conduct all activities with an unwavering focus on compliance.
• In depth knowledge of global CMC guidelines regarding IND/BLAs or post approval changes.
• Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines.
• Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
• Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
• Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required, as needed.

Position Qualifications:

• B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry, Chemical Engineering, or Biochemistry.

Required Experience and Skills:

• At least 10 years of relevant experience (5 years with advanced degree) of Regulatory CMC or directly relevant pharmaceutical development experience in small molecules or other chemically synthesized modalities, including experience in process chemistry, analytical development, manufacturing, testing, quality, technical operations, or CMC product development.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders

Preferred Experience and Skills:

• Experience supporting pre-and-post approval CMC regulatory submissions, health authority interactions, or development of drug-linkers, payloads, ADCs, peptides, oligonucleotides, or other bio-conjugate or new-modality products. Experience with external development or manufacturing partners and global life-cycle management is also preferred.

Required Skills:

Adaptability, Analytical Chemistry, Antibody Drug Conjugates (ADC), Biochemistry, Biologics, Biologics License Application (BLA), Bioproducts, Biosimilars, Chemistry, Cross-Cultural Awareness, Detail-Oriented, Drug Formulations, Electronic Common Technical Document (eCTD), Employee Training Programs, External Manufacturing, Global Coordination, International Regulatory Compliance, Investigational New Drug, Next Generation Science Standards, Pharmaceutical Process Development, Pharmaceutics, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance {+ 7 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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 characteristics. As 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

$142,400.00 - $224,100.00

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. More information about benefits is available at

You 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

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

1