Senior Scientist, Biologics & Vaccine Analytics
Job Description New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment. Position Description:
Our Biologics and Vaccines Analytics (BVA) team is seeking a Senior Scientist. Biologics and Vaccines Analytics (BVA) is a group within our Manufacturing Division, which manages commercialization of vaccines and biologics throughout launch to supply. BVA provides analytical development, optimization, and promotion through a product's life cycle. Activities within this dynamic environment include interfacing with a global network of product manufacturing and testing, collaborating with product development groups within our Manufacturing and our Research and Development divisions, oversight of analytical control organizations, managing assay validation and transfer activities, as well as Biologics License Application preparation. Additional Tasks Direct an analytical working group for late-stage/commercial biologics program. Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of large molecule (biologics) analytics Coordinate with analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and technology transfers between our Company, external partners and CMO/CROs. Contribute to and coordinate analytical activities across multiple projects. Guide cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel biologics. Steer teams of subject matter experts to develop and optimize biochemical, immuno-chemical and chromatography-based analytical methods. Prepare and execute analytical method transfers and assay method validations, including authoring and coordinating review of protocols and reports. Provide on-going support to internal staff and external partners to resolve analytical issues and trouble-shooting. Develop and execute critical reagent protocols for qualification and stability studies. Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods. Coordinate analytical issue resolution via subject matter experts within the global biologics networks. Required
Qualifications:
Education and
Experience:
Bachelor's of Science (Biology, Chemistry, Biochemistry or related sciences) AND five (5) years of working in a related role OR Master's of Science AND three (3) years of working in a related role , OR Ph.D. in biochemistry, molecular/cellular biology, or equivalent bio-related science plus two (2) years of working in a related role. Knowledge and Skills:
Minimum two (2) years of large molecule (vaccine or biologics) method development, validation, or project management Minimum of two (2) years of working knowledge of a GMP laboratory environment Ability to work within and direct Cross-Functional Team Learn new techniques and multi-task with minimal supervision Detailed oriented with strategic, efficient, and effective project management capabilities General knowledge of drug substance and drug product release, stability and extended characterization testing for vaccines and/or biologics Strong technical, verbal, and written communication, interpersonal and teamwork skills Ability to travel up to 25% Preferred
Qualifications:
Continuous improvement or Project Management training Global supply or launch Promoting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA) Authoring and/or reviewing technical documents to promote Process Performance Qualification (PPQ) Analytical or Project guide knowledge Method transfer with an external contract laboratory or global sites Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time. Who we are We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. 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. 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. For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster EEOC GINA Supplement OFCCP EEO 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
No relocation VISA Sponsorship:
No Travel Requirements:
25% Flexible Work Arrangements:
Shift:
1st - Day Valid Driving License:
No Hazardous Material(s):
No Number of Openings:
1
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Our Biologics and Vaccines Analytics (BVA) team is seeking a Senior Scientist. Biologics and Vaccines Analytics (BVA) is a group within our Manufacturing Division, which manages commercialization of vaccines and biologics throughout launch to supply. BVA provides analytical development, optimization, and promotion through a product's life cycle. Activities within this dynamic environment include interfacing with a global network of product manufacturing and testing, collaborating with product development groups within our Manufacturing and our Research and Development divisions, oversight of analytical control organizations, managing assay validation and transfer activities, as well as Biologics License Application preparation. Additional Tasks Direct an analytical working group for late-stage/commercial biologics program. Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of large molecule (biologics) analytics Coordinate with analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and technology transfers between our Company, external partners and CMO/CROs. Contribute to and coordinate analytical activities across multiple projects. Guide cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel biologics. Steer teams of subject matter experts to develop and optimize biochemical, immuno-chemical and chromatography-based analytical methods. Prepare and execute analytical method transfers and assay method validations, including authoring and coordinating review of protocols and reports. Provide on-going support to internal staff and external partners to resolve analytical issues and trouble-shooting. Develop and execute critical reagent protocols for qualification and stability studies. Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods. Coordinate analytical issue resolution via subject matter experts within the global biologics networks. Required
Qualifications:
Education and
Experience:
Bachelor's of Science (Biology, Chemistry, Biochemistry or related sciences) AND five (5) years of working in a related role OR Master's of Science AND three (3) years of working in a related role , OR Ph.D. in biochemistry, molecular/cellular biology, or equivalent bio-related science plus two (2) years of working in a related role. Knowledge and Skills:
Minimum two (2) years of large molecule (vaccine or biologics) method development, validation, or project management Minimum of two (2) years of working knowledge of a GMP laboratory environment Ability to work within and direct Cross-Functional Team Learn new techniques and multi-task with minimal supervision Detailed oriented with strategic, efficient, and effective project management capabilities General knowledge of drug substance and drug product release, stability and extended characterization testing for vaccines and/or biologics Strong technical, verbal, and written communication, interpersonal and teamwork skills Ability to travel up to 25% Preferred
Qualifications:
Continuous improvement or Project Management training Global supply or launch Promoting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA) Authoring and/or reviewing technical documents to promote Process Performance Qualification (PPQ) Analytical or Project guide knowledge Method transfer with an external contract laboratory or global sites Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time. Who we are We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. 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. 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. For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster EEOC GINA Supplement OFCCP EEO 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
No relocation VISA Sponsorship:
No Travel Requirements:
25% Flexible Work Arrangements:
Shift:
1st - Day Valid Driving License:
No Hazardous Material(s):
No Number of Openings:
1
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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