Job Description

Our company’s Device Development (DD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DD Team manages the development of the device constituent of our company’s pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.

Job Description:

The Device Development & Technology department within our Company Research Labs is seeking a talented, self-motivated, and highly collaborative Associate Principal Scientist (Engineer) with solid knowledge of container closure integrity (CCI) technology and experience with test method development, testing, and method validation for various product images (vials, syringes, cartridges, and injectors) and secondary packaging. Candidate will develop and oversee CCI strategy for our Company’s combination product pipeline, inclusive of small molecule, biologics, and vaccine products.

The successful candidate will have experience in method development, validation and/or testing of typical injectable product presentations and be familiar with current industry and regulatory standards/best practices and innovative approaches for demonstration of container-closure system attributes.

Education/Work Experience Minimum Qualifications:

• B.S. in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with 8 years of relevant work experience in the pharmaceutical, biotechnology, or medical device industries

• M.S. in the above fields with 6 years of relevant work experience

• Ph.D. in the fields above with 3 years of relevant work experience

Required Experience & Skills:

• Hands-on experience in CCIT method development, validation and troubleshooting for injectable therapeutics. Candidate should be a subject matter expert (SME) with the following CCIT technologies for this purpose: dye ingress, high voltage leak detection, Helium leak detection, vacuum and pressure decay, laser headspace analysis, mass extraction, and CO2 ingress.

• Experience in day-to-day oversight of laboratory analysts performing CCIT method development and validation. Direct experience with combination products strongly preferred.

• Prior experience in test method technology transfer and day-to-day oversight and SME support of contract testing organizations performing release, stability or characterization testing on combination products (small molecule, biologic and vaccine).

• Experience with CCI-related GMP investigations and deviation (OOS & OOT) management.

• Strong knowledge of current global regulatory standards and best practices related to all aspects of CCIT .

• Proven ability to foster a culture of innovation, collaboration, and technical excellence with junior scientist/engineers.

• Excellent organizational skills to manage multiple projects.

• Good written and oral communication skills.

• Ability to collaboratively work and lead in a multi-functional & -disciplinary working environment.

Preferred Experience and Skills:

• Experience in biologic and/or vaccine drug product manufacturing, process development, inspection and release testing.

• Training and proficiency in current good manufacturing practices (cGMP).

• Successful track record of management of a biologics or vaccines quality control or analytical development laboratory.

• Experience in authoring of regulatory documentation (IND, CTA, NDA, BLA) and interaction with health authorities.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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 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:

$135,500.00 - $213,400.00

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 (https://www.benefitsatmerck.com/) .

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/22/2024

*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.

Requisition ID: R319922