2025 University Recruiting - Regulatory Chemistry, Manufacturing, & Controls (CMC) Intern - Military Veterans

Job Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to identify and isolate a molecule that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics understanding of how formulation impacts exposure of compounds in humans spanning the oral and non-oral portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and execute a comprehensive biopharmaceutics strategy that leverages cutting edge in vitro, in vivo and in silico physiologically based pharmacokinetics (PBPK) and PK modeling tools, while advancing the underlying biopharmaceutics science within the organization and the external scientific community. The successful candidate:

• Should have a vision to develop a team, demonstrated leadership skills, biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory environment


• Will be responsible for sub-functional strategic planning, coordinating, and execution of initiatives supporting the interfaces between the biopharmaceutics team and various discovery and development departments


• Will need to collaborate in a fast-paced, integrated, multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impact


• Proactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting hypothesis-based assessment employing a rigorous integrated approach, driving the development of in vitro-in vivo relationships and preclinical-to-clinical translation in bioperformance of formulations

The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists. The successful candidate will effectively partner with Biologics and Biopharmaceutics leadership and extended leadership teams to implement strategy, conduct scientific research, step across boundaries and resource programs in a phase appropriate manner. The incumbent will be responsible for the recruiting, appraisal, and development of personnel under her/his supervision to their full potential. The Director selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under her/his direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a proven track record of developing talent from a diverse scientific background and will have the ability to advance our commitment to a diverse and inclusive work environment. Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence and compliance mindset.

Essential Knowledge, Duties & Responsibilities for the Director Include:

• Biopharmaceutics expertise supporting delivery of small molecule, peptides and biologic modalities


• Review and approval of data and technical documents including critical evaluation of predictive models


• Ability to recruit, select, develop, and mentor talent


• Strategic and critical thinking to advance biopharmaceutics strategy across the portfolio


• Project management skills


• Attention to technical detail


• Builds collaborations across internal departments and key stakeholders


• Ability to lead and champion organizational structure and be a change agent when necessary


• Manage the departmental budget and meeting the agreed upon spend

Qualifications:

Education:

• Ph.D. in Pharmaceutics, Pharmacokinetics, Biopharmaceutical sciences, Pharmaceutical sciences or relevant field with minimum of 10 years of industrial experience.


• B.S. or M.S. in Pharmaceutics, Pharmacokinetics, Biopharmaceutical sciences, Pharmaceutical sciences or relevant field with minimum of 12 years of industrial experience

Required:

• Advanced knowledge in pharmacokinetics and understanding of principles of physiologically-based pharmacokinetic modeling


• Develop/Evaluate physiologically-based pharmacokinetic (PBPK) models to facilitate decisions in areas including formulation development, food effect evaluation, in vitro-in vivo correlations and dissolution specification setting


• Strong knowledge of formulation development of small molecules


• Relevant experience in pharmaceutical development with exposure to all stages and aspects of development (pre-clinical, clinical, and commercial)


• Strong influencing and communication skills and demonstrated ability and creativity in solving tough problems.


• Demonstrated strong verbal as well as written communication skills and ability to work effectively with team-members of diverse skill sets and backgrounds


• Demonstrated self-motivation to take ownership and accountability of issues and drive them to completion


• A track record of scientific publications in the field


• Candidate should have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations, Non-clinical, Clinical, and other functional areas


• Experience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.


• Must be innovative and drive new ideas, but also have pragmatic approach to development options, technology selection and regulatory posture


• Demonstrated ability to identify, mitigate and clearly articulate program risks

Preferred Experience and Skills:

• Hands-on experience with physiologically-based pharmacokinetics modeling software (e.g., Simcyp, GastroPlus) is highly desired.


• Experience in regulatory compliance expectations across all phases of product development to commercialization


• Experience with in silico, in vitro, and in vivo predictive tools for subcutaneous biologics absorption


• Demonstrated leadership skills and organization design (i.e. building high performing teams, building talent, and shown to be able to motivate, influence scientific team; lead by example through past scientific / technical expertise).


• Highly motivated, flexible, a change agent, and ability to work in a fast-paced environment.


• Encourages innovative thinking / risk-taking and eliminates obstacles / barriers to implement change


• Ability to engage and align other stakeholders outside the project team.


• Ability to apply and promote a growth mindset with teams and partnerships

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

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

Learn more about your rights, including under California, Colorado and other US State Acts

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, generally Tuesday, Wednesday and either Monday or 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:
$164,800.00 - $259,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here .

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:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
10/7/2024
*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.