Senior Scientist, Regulatory CMC Biologics

Job Description

Senior Scientist, Regulatory CMC Biologics

Position Description

• Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological projects. Be accountable for the delivery of all regulatory milestones through product development and / or post approval life cycle.
• Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory CMC requirements and identification of potential risks.
• Manage execution of CMC documentation including IND/IMPD, original BLA/MAA, or Post approval / variations, agency background packages and responses to health authority questions per established business processes and systems.
• Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management, as needed
• Conduct all activities with an unwavering focus on compliance

Position Qualifications

Education Minimum Requirement:

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

Required Experience And Skills

• 5 years of Regulatory CMC related experience, relevant experience including biological or vaccine drug substance/drug product development research, or manufacturing, testing and/or related field.

Preferred Experience And Skills

• Experience in biologics Regulatory CMC preferred.

Required Skills

Business Processes, CMC Documentation, CMC Strategy, Detail-Oriented, Document Coordination, Drug Product Development, Interpersonal Relationships, Pharmaceutical Products, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Interpretation, Regulatory Project Management, Regulatory Strategy Development, Writing Technical Documents

Preferred Skills

CMC Biologics

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US And Puerto Rico Residents Only

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Requirements

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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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