Hispanic Alliance for Career Enhancement
Principal Scientist, Analytical R&D
Hispanic Alliance for Career Enhancement, West Point, Pennsylvania, us, 19486
Overview
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 isolate a compound that is effective against a disease target. We deliver robust scientific data and interpretation that drives the development and commercialization of breakthrough therapeutics. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Analytical Research and Development, Cell Based Sciences Department in West Point, PA is seeking a Principal Scientist with technical expertise in developing large molecule potency assays. In this role, an individual will work closely with the group Director to define technical and scientific strategies and lead a team of scientists in solving complex analytical problems to facilitate the development of vaccines. The ideal candidate will be an expert in developing mechanism-of-action reflective potency assays for the development of multi-valent recombinant vaccine products. We are looking for a collaborator with strong leadership skills and ability and passion for mentoring and working with others in a laboratory setting. This position will involve leading laboratory development to drive understanding of vaccine development, partnering across functions and divisions to strategically apply that understanding to deliver the best analytical science in the process and product will be key to success. The successful candidate is expected to provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio. Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior written and oral communications skills. The candidate will be expected to effectively communicate with stakeholders in partner organizations and to management and governance teams. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific excellence supported by publications and external presentations is expected. Primary Responsibilities
Lead, supervise, and mentor a team of scientists developing analytical methods and defining the potency strategy for our large molecule portfolio. Provide analytical leadership not only on vaccine development pipeline projects, but also innovative technology teams shaping analytical methods and tools of the future. Representing the group on product development teams, Work and collaborate effectively in a multidisciplinary team environment and provide technical input to enable team decisions. Lead in authoring and reviewing scientific documents including development reports, analytical method protocols, qualification protocols, and electronic notebooks. Work and collaborate effectively in a multidisciplinary team environment and provide technical input to enable team decisions. Be a leader within the external scientific community in professional organizations, conferences, and publications as well as analytical technology and regulatory sciences related focus groups and consortia. Education Requirements
Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field with a minimum of 8 years of relevant experience in Biopharmaceutical Industry; OR M.S. with a minimum of 10 years of relevant experience in Biopharmaceutical Industry; OR Bachelor's with a minimum of 14 years of relevant experience in Biopharmaceutical Industry. Required Skills and Experience
In-depth knowledge and understanding of immunoassay development including antigen and antibody selection, antibody matched pair screening and optimization, binding kinetics, and multiplexing. Expertise in cell biology and immunology, with application to solve complex scientific challenges related to designing and developing GxP potency assays to support a variety of vaccine modalities. Demonstrated ability to lead complex experimental design and detailed data analysis concepts related to analytical method development. Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities. Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner. External scientific engagement demonstrated through publications, regulatory guidance documents, industry white paper contributions, presentations at scientific meetings, and/or membership on (or leading) cross-company working groups or consortia. Excellent verbal and written communications skills. Please note that this lab-based role is not eligible for our hybrid work model, but we are committed to promoting work-life balance and offer other flexible arrangements where feasible. #AR&D Current Employees apply HERE Current Contingent Workers apply HERE Additional Information
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 characteristics. As 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: EEOC Know Your Rights, EEOC GINA Supplement. 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 another's thinking and approach problems collectively. 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, with Friday remote, unless business critical tasks require on-site presence. This model does not apply to field-based, facility-based, manufacturing-based, or research-based positions where work is at a Company site, or positions with collective-bargaining agreements unless allowed. It also does not apply to roles designated as remote. Salary Range:
This role offers $153,800.00 - $242,200.00. Salary placement within the range depends on education, qualifications, certifications, experience, skills, location, and business needs. The candidate may be eligible for annual bonus and long-term incentives, if applicable. Benefits
A comprehensive package includes medical, dental, vision, retirement benefits (401(k)), holidays, vacation, and sick days. More information at https://jobs.merck.com/us/en/compensation-and-benefits. Application
You can apply for this role through https://jobs.merck.com/us/en or via the Workday Jobs Hub if you are a current employee. The application deadline is stated on this posting. Location-Specific Notices
San Francisco residents: Fair Chance Ordinance; Los Angeles residents: applicable state and local laws; Search Firm Representatives: Merck does not accept unsolicited assistance without a valid written agreement. Employee Status:
Regular Relocation:
Domestic/International VISA Sponsorship:
Yes Travel Requirements:
10% Flexible Work Arrangements:
Not Applicable Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
n/a Required Skills
Accountability, Analytical Chemistry, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biologics License Application (BLA), Biopharmaceutical Industry, Biopharmaceuticals, Chromatographic Techniques, Clinical Judgment, Communication, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, Immunoassays, Liquid Chromatography (LC), Mentoring Staff, Method Validation, Molecular Biology
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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 isolate a compound that is effective against a disease target. We deliver robust scientific data and interpretation that drives the development and commercialization of breakthrough therapeutics. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Analytical Research and Development, Cell Based Sciences Department in West Point, PA is seeking a Principal Scientist with technical expertise in developing large molecule potency assays. In this role, an individual will work closely with the group Director to define technical and scientific strategies and lead a team of scientists in solving complex analytical problems to facilitate the development of vaccines. The ideal candidate will be an expert in developing mechanism-of-action reflective potency assays for the development of multi-valent recombinant vaccine products. We are looking for a collaborator with strong leadership skills and ability and passion for mentoring and working with others in a laboratory setting. This position will involve leading laboratory development to drive understanding of vaccine development, partnering across functions and divisions to strategically apply that understanding to deliver the best analytical science in the process and product will be key to success. The successful candidate is expected to provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio. Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior written and oral communications skills. The candidate will be expected to effectively communicate with stakeholders in partner organizations and to management and governance teams. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific excellence supported by publications and external presentations is expected. Primary Responsibilities
Lead, supervise, and mentor a team of scientists developing analytical methods and defining the potency strategy for our large molecule portfolio. Provide analytical leadership not only on vaccine development pipeline projects, but also innovative technology teams shaping analytical methods and tools of the future. Representing the group on product development teams, Work and collaborate effectively in a multidisciplinary team environment and provide technical input to enable team decisions. Lead in authoring and reviewing scientific documents including development reports, analytical method protocols, qualification protocols, and electronic notebooks. Work and collaborate effectively in a multidisciplinary team environment and provide technical input to enable team decisions. Be a leader within the external scientific community in professional organizations, conferences, and publications as well as analytical technology and regulatory sciences related focus groups and consortia. Education Requirements
Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field with a minimum of 8 years of relevant experience in Biopharmaceutical Industry; OR M.S. with a minimum of 10 years of relevant experience in Biopharmaceutical Industry; OR Bachelor's with a minimum of 14 years of relevant experience in Biopharmaceutical Industry. Required Skills and Experience
In-depth knowledge and understanding of immunoassay development including antigen and antibody selection, antibody matched pair screening and optimization, binding kinetics, and multiplexing. Expertise in cell biology and immunology, with application to solve complex scientific challenges related to designing and developing GxP potency assays to support a variety of vaccine modalities. Demonstrated ability to lead complex experimental design and detailed data analysis concepts related to analytical method development. Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities. Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner. External scientific engagement demonstrated through publications, regulatory guidance documents, industry white paper contributions, presentations at scientific meetings, and/or membership on (or leading) cross-company working groups or consortia. Excellent verbal and written communications skills. Please note that this lab-based role is not eligible for our hybrid work model, but we are committed to promoting work-life balance and offer other flexible arrangements where feasible. #AR&D Current Employees apply HERE Current Contingent Workers apply HERE Additional Information
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 characteristics. As 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: EEOC Know Your Rights, EEOC GINA Supplement. 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 another's thinking and approach problems collectively. 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, with Friday remote, unless business critical tasks require on-site presence. This model does not apply to field-based, facility-based, manufacturing-based, or research-based positions where work is at a Company site, or positions with collective-bargaining agreements unless allowed. It also does not apply to roles designated as remote. Salary Range:
This role offers $153,800.00 - $242,200.00. Salary placement within the range depends on education, qualifications, certifications, experience, skills, location, and business needs. The candidate may be eligible for annual bonus and long-term incentives, if applicable. Benefits
A comprehensive package includes medical, dental, vision, retirement benefits (401(k)), holidays, vacation, and sick days. More information at https://jobs.merck.com/us/en/compensation-and-benefits. Application
You can apply for this role through https://jobs.merck.com/us/en or via the Workday Jobs Hub if you are a current employee. The application deadline is stated on this posting. Location-Specific Notices
San Francisco residents: Fair Chance Ordinance; Los Angeles residents: applicable state and local laws; Search Firm Representatives: Merck does not accept unsolicited assistance without a valid written agreement. Employee Status:
Regular Relocation:
Domestic/International VISA Sponsorship:
Yes Travel Requirements:
10% Flexible Work Arrangements:
Not Applicable Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
n/a Required Skills
Accountability, Analytical Chemistry, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biologics License Application (BLA), Biopharmaceutical Industry, Biopharmaceuticals, Chromatographic Techniques, Clinical Judgment, Communication, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, Immunoassays, Liquid Chromatography (LC), Mentoring Staff, Method Validation, Molecular Biology
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