Executive Director, Biologics Analytical Research and Development at Merck Sharp & Dohme (MSD)
Rahway, NJ 07065
About the Job
Job DescriptionOur 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
Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.Our team in Rahway, New Jersey, is seeking an exceptional leader who is passionate about leading a team of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products
The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across modalities and will partner with cross-functional development teams to enable pipeline decisions
The Executive Director, Biologics Analytical Research and Development (B-AR&D) is responsible for providing strategic and technical leadership for analytical development of candidates from the discovery interface, through first product registration
They will be responsible for a portfolio of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists
Strategic partnering with Biologics Analytical Research and Development method development GMP laboratories, complementary areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment
Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, including strong background and experience in separations science, extensive experience with UPLC/HPLC analysis of biologics (e.g
SEC, RP, IEX), experience in microbiological techniques, ELISA, PCR, cell based analytics, background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications
The incumbent will be responsible for the recruiting, appraisal and development of personnel under their supervision.The Executive Director selects, trains, and effectively works with colleagues to action development plans of personnel under their direction within the framework of Company policy
The Executive Director will be a manager of managers, with keen focus on coaching and mentoring organizational leaders in talent Development
The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit and promotion planning)
Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, compliance mindset and collaboration with various partners and stakeholders in development.Education:BS Degree with 17+ years of relevant experience or MS with 10+ years of relevant experience or Ph.D
in analytical chemistry or related field with 8+ years of relevant experience in the pharmaceutical industryRequired Experience and Skills:Excellent verbal and written communication skills, demonstrated creativity, strong interpersonal and collaborative skills Demonstrated ability in leading cross-functional groups with proven talent development skillsets.Ability to work in a team environment with cross-functional interactions is essentialStrength in delivering results on firm deadlines in support of compound from development through CommercializationA strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.NOTICE FOR INTERNAL APPLICANTSIn 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 HERECurrent Contingent Workers apply HEREUS 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.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 RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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 ActsU.S
Hybrid Work ModelEffective 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:$243,500.00 - $383,300.00Available 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 OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation:Domestic/InternationalVISA Sponsorship:YesTravel Requirements:10%Flexible Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:11/11/2024*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
SummaryLocation: USA - New Jersey - RahwayType: Full time
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
Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.Our team in Rahway, New Jersey, is seeking an exceptional leader who is passionate about leading a team of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products
The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across modalities and will partner with cross-functional development teams to enable pipeline decisions
The Executive Director, Biologics Analytical Research and Development (B-AR&D) is responsible for providing strategic and technical leadership for analytical development of candidates from the discovery interface, through first product registration
They will be responsible for a portfolio of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists
Strategic partnering with Biologics Analytical Research and Development method development GMP laboratories, complementary areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment
Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, including strong background and experience in separations science, extensive experience with UPLC/HPLC analysis of biologics (e.g
SEC, RP, IEX), experience in microbiological techniques, ELISA, PCR, cell based analytics, background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications
The incumbent will be responsible for the recruiting, appraisal and development of personnel under their supervision.The Executive Director selects, trains, and effectively works with colleagues to action development plans of personnel under their direction within the framework of Company policy
The Executive Director will be a manager of managers, with keen focus on coaching and mentoring organizational leaders in talent Development
The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit and promotion planning)
Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, compliance mindset and collaboration with various partners and stakeholders in development.Education:BS Degree with 17+ years of relevant experience or MS with 10+ years of relevant experience or Ph.D
in analytical chemistry or related field with 8+ years of relevant experience in the pharmaceutical industryRequired Experience and Skills:Excellent verbal and written communication skills, demonstrated creativity, strong interpersonal and collaborative skills Demonstrated ability in leading cross-functional groups with proven talent development skillsets.Ability to work in a team environment with cross-functional interactions is essentialStrength in delivering results on firm deadlines in support of compound from development through CommercializationA strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.NOTICE FOR INTERNAL APPLICANTSIn 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 HERECurrent Contingent Workers apply HEREUS 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.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 RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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 ActsU.S
Hybrid Work ModelEffective 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:$243,500.00 - $383,300.00Available 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 OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation:Domestic/InternationalVISA Sponsorship:YesTravel Requirements:10%Flexible Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:11/11/2024*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
SummaryLocation: USA - New Jersey - RahwayType: Full time
