Senior Scientist Engineering
Senior Scientist Engineering
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$ 111400 - 175300
1 Vacancy
Job Description
Job Description
As part of Our Companys Manufacturing Division within the Bioprocess Drug Substance Commercialization (BDSC) the Bioconjugation and Chemistry (BCC) team provides the technical process leadership and laboratory capabilities in support of latestage pipeline and postmarket commercial manufacturing processes for biologically derived drug substances (e.g. therapeutic proteins antibody drug conjugates or vaccines) generated from bioconjugation processes.
For latestage pipeline commercialization activities include process characterization technology transfer to internal and external manufacturing sites process validation and authoring of regulatory submissions. For commercial programs activities include sitetosite process transfers manufacturing investigations and trend evaluations process enhancements next generation process development and characterization process validation and regulatory submission authoring.
This role may require working outside of core business hours to support lab studies and/or onsite activities related to tech transfer and manufacturing. This role may also require approximately 25 of time spent on domestic (e.g. to Rahway NJ site) or international travel.
In this role the successful candidate will be responsible for:
- Technical leadership on design planning and executing laboratory experiments and investigations for the purposes of mechanistic understanding and to enable process development problem solving and to reduce risk inherent in scale up or scale down of drug substance / bioconjugation processes.
- Responsible for planning or executing scale studies to support commercial process validation process characterization and investigation evaluations including studies performed either inhouse or externally.
- Design plan and execute laboratory experiments to generate high quality data. Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports.
- Authors experimental protocols and documents work in a lab notebook.
- Documents lab activities findings and conclusions in scientific reports and presents knowledge at appropriate forums. Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal state and local regulations.
- May be responsible for managing multifaceted projects as the leader of a crossfunctional team. As an individual contributor may be concerned with clearly identifiable elements or functions within a larger project team.
Education & Experience:
- Bachelors Degree in Engineering Science or related field with a minimum of four 4 years of large molecule/antibody drug conjugate and/or commercialization experience; OR
- Masters Degree with a minimum of three 3 years of large molecule/antibody conjugate experience; OR
- Doctoral Degree (Ph.D. with no 0 years of experience.
Required Skills and Experience:
- Experience with large molecule manufacturing processes including onthefloor GMP manufacturing support
- Experience designing process development experiments using riskbased methodology or similar
- Experience with latestage commercial process development technology transfer scaledown model qualification and process characterization
- Experience authoring technical documentation in support of the following: process performance qualification risk assessment control strategy process comparability reports and/or regulatory submissions such as BLAs INDs or other regulatory source documentation
- Ability to work effectively in crossfunctional and matrixed team environment; collaborate with both internal and external partners including vendors
- Possesses outstanding communication skills
- Ability to coach others and manage small teams effectively
Preferred Skills and Experience:
- Experience with bioconjugation or antibody drug conjugate processes
- Experience interacting with and overseeing commercialization activities at both internal and external manufacturing sites
- Experience with process scaleup and/or technology transfer moving from laboratory to pilot plant or production scale or similar
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 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:
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 anothers thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.
Expected US salary range:
$111400.00 $175300.00Available 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.
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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
Domestic/InternationalVISA Sponsorship:
YesTravel Requirements:
25Flexible Work Arrangements:
HybridShift:
1st DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/3/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Senior IC
Employment Type
Full-Time
