Merck Sharp & Dohme
Director, Small Molecule Analytical Research and Development
Merck Sharp & Dohme, Rahway, New Jersey, us, 07065
Job Description
Join us to be part of a team of inventors to make a change in our patients' life! Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
The primary objective of the Small Molecule Analytical Research and Development (SMAR&D) team is to carry out R&D activities partnering across the network to enable process and formulation development. In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, and packaging components for our research pipeline. This research opportunity contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable which is the development of robust chemical and biochemical processes, market formulations and their processes for non-sterile and sterile products. It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing division.
This challenging position requires deep understanding of new commercial product development and commercialization, proactively identifying risks to influence solutions, driving operational and scientific excellence, actively engaging in two-way communication to build trusting relationships, providing timely feedback and coaching to talent within their organizations, and solving problems in innovative ways to achieve results.
Nature and Scope of Position:
The Director reports to the Executive Director of SMAR&D and will lead a team in Rahway (~10-15 scientists) who work closely within multidisciplinary DSCS teams. This role has a wide responsibility for analytical method development, and testing for chemical and biochemical processes, parenteral, oral, and specialty dosage formulations. The director should be well engaged with regulatory and industry trends to guide future activities for Analytical R&D and DSCS. The candidate will have experience in an innovative analytical/regulatory/GMP environment.
The Director will effectively team with the SMAR&D leadership, and extended leadership teams in order to identify and advance key departmental strategic and cultural initiatives. The Director will identify, recruit, onboard and develop employees to their full potential. The candidate will contribute and establish a viable succession plan for key positions within the functional area (scientific and management pathways), including their own role. The position is responsible for disclosures prepared within the group to be used as the basis for external publications and filings. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.
Maintaining an effective network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.
Essential Knowledge, Duties & Responsibilities include:
Analytical Methodologies
Project management skills
Review and approval of data
Representation of the laboratory for internal and external audits
SOP development
Quality System experience
Team and staff development
Thorough working knowledge of GMPs, ICH, Major compendia, and relevant FDA guidelines
Qualifications:
Education:
BS or MS in chemistry or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development.
Ph.D. in chemistry or related science with 7 years of industrial experience with pharmaceutical drug substance and/or product development.
Required:
Demonstrated ability in leading teams with proven talent development skillsets.
Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills.
Ability to work in a team environment with cross-functional interactions is essential.
Strength in delivering results on firm deadlines in support of drug substance and product development and commercial filing.
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.
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.
Expected US salary range: $164,800.00 - $259,400.00
Available 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.
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.
Employee Status:
Regular
Job Posting End Date:
12/5/2024
#J-18808-Ljbffr
Join us to be part of a team of inventors to make a change in our patients' life! Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
The primary objective of the Small Molecule Analytical Research and Development (SMAR&D) team is to carry out R&D activities partnering across the network to enable process and formulation development. In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, and packaging components for our research pipeline. This research opportunity contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable which is the development of robust chemical and biochemical processes, market formulations and their processes for non-sterile and sterile products. It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing division.
This challenging position requires deep understanding of new commercial product development and commercialization, proactively identifying risks to influence solutions, driving operational and scientific excellence, actively engaging in two-way communication to build trusting relationships, providing timely feedback and coaching to talent within their organizations, and solving problems in innovative ways to achieve results.
Nature and Scope of Position:
The Director reports to the Executive Director of SMAR&D and will lead a team in Rahway (~10-15 scientists) who work closely within multidisciplinary DSCS teams. This role has a wide responsibility for analytical method development, and testing for chemical and biochemical processes, parenteral, oral, and specialty dosage formulations. The director should be well engaged with regulatory and industry trends to guide future activities for Analytical R&D and DSCS. The candidate will have experience in an innovative analytical/regulatory/GMP environment.
The Director will effectively team with the SMAR&D leadership, and extended leadership teams in order to identify and advance key departmental strategic and cultural initiatives. The Director will identify, recruit, onboard and develop employees to their full potential. The candidate will contribute and establish a viable succession plan for key positions within the functional area (scientific and management pathways), including their own role. The position is responsible for disclosures prepared within the group to be used as the basis for external publications and filings. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.
Maintaining an effective network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.
Essential Knowledge, Duties & Responsibilities include:
Analytical Methodologies
Project management skills
Review and approval of data
Representation of the laboratory for internal and external audits
SOP development
Quality System experience
Team and staff development
Thorough working knowledge of GMPs, ICH, Major compendia, and relevant FDA guidelines
Qualifications:
Education:
BS or MS in chemistry or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development.
Ph.D. in chemistry or related science with 7 years of industrial experience with pharmaceutical drug substance and/or product development.
Required:
Demonstrated ability in leading teams with proven talent development skillsets.
Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills.
Ability to work in a team environment with cross-functional interactions is essential.
Strength in delivering results on firm deadlines in support of drug substance and product development and commercial filing.
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.
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.
Expected US salary range: $164,800.00 - $259,400.00
Available 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.
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.
Employee Status:
Regular
Job Posting End Date:
12/5/2024
#J-18808-Ljbffr