Sr Principal Scientist Sterile Product Development
Sr Principal Scientist Sterile Product Development
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 187000 - 294400
1 Vacancy
Job Description
Job Description
The Sterile and Specialty Products (SSP) group is responsible for developing nonoral dosage forms (injections implants inhaled ocular) for small intermediate and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition primary packaging/device and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability safety efficacy and delivery. During development we leverage smart experimental design cutting edge analytical tools and predictive approaches to inform molecule formulation and process selection. In summary our team enables the translation of preclinical candidates into nonoral drug products.
Our team is looking for a strong candidate for the position of Senior Principal Scientist within the Biologics product development group.
Primary duties:
- Be a seasoned biologics product developer responsible for designing and developing sterile products for injectables and ocular drug products.
- Support both early and latestage development candidates that will include ensuring screening and development of robust drug product composition scalable process primary packaging compatibility characterization for processing and administration and supporting regulatory filings.
- Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small group of scientists during product development to ensure completion of key milestones and laboratory / regulatory documentation.
- Active strategic and technical leadership to influence program development teams interfacing with key stakeholders and collaborating across functions to drive defined milestones will be required.
- Outstanding communication skills and the ability to clearly articulate risks and tradeoffs experienced within product development to appropriate governance venues and management
- Responsible for ideating leading and championing organizational strategic and innovation objectives aligned with organizational goals.
- Has subject matter expertise with process scale up modeling regulatory filings for commercialization and/or driving key capability evaluation/ build
- Be willing to take initiative motivated to excel have a strong technical background have excellent communication and interpersonal skills ability to multitask mentor scientists and a strong desire to learn and contribute.
- Proven demonstration of leadership behaviors
- Be a change agent for continuous improvement of internal processes contextualizing the broader portfolio outside of their assigned programs.
Education Minimum Requirement:
- Masters with a minimum of 18 years or Ph.D. with a minimum of 12 years of industry experience and a Degree in Chemical/ Biomedical Engineering Pharmaceutics Pharmaceutical Chemistry Pharmaceutical Sciences Chemistry Biochemistry or related field.
Required Experience and Skills:
- The candidate should have a strong track record in biologics product development including multiple regulatory filings spanning multiple biologic modalities including mAbs ADCs fusion proteins combinations such as doublet or triplet coformulations
- Subject matter expert of process development and process characterization for biologic drug products with proven track record of successful tech transfers to GMP manufacturing sites
- Significant experience with drying technologies such as lyophilization both as a platform technology to enable speed to clinic and deep fundamental understanding of the process and how to optimize
- Strong external presence reflected through multiple external publications and patents.
- The candidate should have experience in designing and executing appropriate DOE studies to inform on biologic drug product risks such as oxidation or light exposure
- The candidate should be wellversed in QbD principles and have experience applying the QbD tools and principles to drug products in development
- The candidate should have strong familiarity with relevant biologic analytical methods and specifications for drug products as well as drug substance downstream formulation considerations
- Subject matter expert in developing and authoring regulatory filings for combination products of biologic therapeutics
- The candidate should have experience desire and a track record of effective mentorship of junior scientists towards timebound goals.
- The candidate should demonstrate scientific leadership in the field of biologics product development
Preferred Experience and Skills:
- Experience in pharmaceutical sciences physical pharmacy physiology pharmacokinetics biochemistry protein sciences chemical kinetics or transport phenomenon is highly desirable.
- Experience in formulation/process definition of critical attributes for process scaleup analytical development and experience with Biologics License Application filing for nonconventional sterile dosage forms including ocular dosage forms or peptide therapeutics and/or alternate delivery technologies (e.g. high concentration hydrogels emulsions suspensions injectable depot) is a plus.
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.
Learn more about your rights including under California Colorado and other US State Acts
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.
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 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:
$187000.00 $294400.00Available 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:
DomesticVISA Sponsorship:
YesTravel Requirements:
10Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/1/2025*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:
Staff IC
Employment Type
Full-Time
