Director, Materials and Biophysical Characterization AR&D

Job Description

Job Summary
We are seeking a highly experienced and motivated individual to join our team as the Director of Biologics- Materials and Biophysical Characterization. The successful candidate will lead our biophysical characterization group in biologics, overseeing the analysis and interpretation of the physical and chemical properties of biopharmaceuticals. This role is critical to ensuring the quality, efficacy, and safety of our products through advanced biophysical techniques and methodologies.

Key Responsibilities

• Lead and manage the biophysical characterization team, providing scientific and technical guidance, mentorship, and support.
• Develop and implement strategic plans for biophysical characterization to support the research and development of biopharmaceuticals.
• Oversee the design, execution, and interpretation of experiments utilizing a range of biophysical techniques, including but not limited to spectroscopy, calorimetry, light scattering, advanced microscopy and chromatography.
• Collaborate with cross-functional teams, including research, development, quality control, and regulatory affairs, to ensure comprehensive biophysical characterization of products.
• Ensure compliance with regulatory guidelines and industry standards related to biophysical characterization.
• Drive innovation and continuous improvement in biophysical characterization techniques and methodologies.
• Prepare and review technical reports, presentations, and documentation for internal and external stakeholders.
• Stay current with advancements in the field of biophysical characterization and integrate new technologies and approaches into the team's work.
• Represent the company in scientific conferences, meetings, and collaborations with external partners.

Education: Ph.D. in Biophysics, Biochemistry, Molecular Biology, or a related field with 8+ years of relevant experience or M.S. in Biophysics, Biochemistry, Molecular Biology, or a related field with 10+ years of relevant experience

Qualifications

• Minimum of 10 years of experience in biophysical characterization, with at least 5 years in a leadership or management role.
• Extensive knowledge and hands-on experience with biophysical characterization, such as particle sizing techniques across a wide range and structural analysis and interpretation using spectroscopy, microscopy, thermal and rheological methods.
• Strong understanding of the principles and applications of biophysical characterization in the context of biopharmaceutical development.
• Proven track record of developing and implementing innovative biophysical characterization strategies.
• Excellent leadership and team management skills, with the ability to inspire and motivate a diverse team of scientists.
• Strong analytical and problem-solving skills, with attention to detail and a commitment to scientific rigor.
• Exceptional communication and interpersonal skills, with the ability to effectively present complex scientific information to a range of audiences.
• Experience with regulatory submissions and compliance related to biophysical characterization.
• Demonstrated ability to work collaboratively in a fast-paced, dynamic environment.

#AR&D

Required Skills:
Accountability, Accountability, Adaptability, Analytical Method Development, Biologics License Application (BLA), Biopharmaceuticals, Chromatographic Techniques, Collaborative Research, Communication, Decision Making, Dosage Forms, Experimental Methods, Mentorship, Microscopies, Molecular Biology, Molecular Microbiology, Multidisciplinary Collaboration, People Leadership, Pharmaceutical Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Submissions {+ 5 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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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.

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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
$169,700.00 - $267,200.00

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. 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
12/26/2025
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R374277