M
Director, Sterile & Specialty Product Development
Salary undisclosed
Apply on
Original
Simplified
Job Description
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. 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 identify and isolate a molecule that is effective against a disease target. 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.
Our company is seeking a highly motivated candidate for the position of Director, Small Molecule Development within the Mixed Modalities, Sterile Product Development (SPD) team. The successful candidate will be expected to lead the team focused on the design of new formulations and development of robust and scalable processes for parenteral drug products within the small molecule and synthetic modality pipeline.
The Director will report to the Executive Director of Sterile Product Development - Mixed Modalities, and lead a team comprised of 10-15 experienced senior and associate scientists. The main responsibilities include leading the small molecule parenteral drug product team that designs and executes experiments to support formulation and process development and document technical reports and regulatory filings. The successful candidate will be key in implementing strategy, conducting scientific research from the laboratory to commercial scale, step across boundaries and implement novel innovations into the drug product space to afford world class parenteral development processes for human health while ensuing a phase appropriate approach and adhering to the highest scientific standard. The incumbent will also be responsible for sub-functional strategic planning, coordinating, and execution of SPD initiatives in the company's portfolio from discovery to launch.
The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The successful candidate will drive the small molecule parenteral portfolio while collaborating with key stakeholders across the organizations (Research Division / Manufacturing Division) to ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic initiatives to advance functional impact. The applicant will also have experience in developing intermediate modalities like oligonucleotides and peptides and have an external network both across industry and academia. Maintaining a strong 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.
The incumbent will also be responsible for the recruiting, appraisal, and development of personnel under her/his supervision. The Director selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under her/his direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a proven track record of developing talent from a diverse scientific background and will have the ability to advance our company's commitment to a diverse and inclusive work environment.
Essential Knowledge, Duties & Responsibilities for the Director Include:
Qualifications:
Education:
Required Experience and Skills:
Preferred Experience and Skills:
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.
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 Rights
EEOC GINA 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.
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 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:
$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. 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 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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/8/2024
*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.
Requisition ID:R316589
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. 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 identify and isolate a molecule that is effective against a disease target. 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.
Our company is seeking a highly motivated candidate for the position of Director, Small Molecule Development within the Mixed Modalities, Sterile Product Development (SPD) team. The successful candidate will be expected to lead the team focused on the design of new formulations and development of robust and scalable processes for parenteral drug products within the small molecule and synthetic modality pipeline.
The Director will report to the Executive Director of Sterile Product Development - Mixed Modalities, and lead a team comprised of 10-15 experienced senior and associate scientists. The main responsibilities include leading the small molecule parenteral drug product team that designs and executes experiments to support formulation and process development and document technical reports and regulatory filings. The successful candidate will be key in implementing strategy, conducting scientific research from the laboratory to commercial scale, step across boundaries and implement novel innovations into the drug product space to afford world class parenteral development processes for human health while ensuing a phase appropriate approach and adhering to the highest scientific standard. The incumbent will also be responsible for sub-functional strategic planning, coordinating, and execution of SPD initiatives in the company's portfolio from discovery to launch.
The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The successful candidate will drive the small molecule parenteral portfolio while collaborating with key stakeholders across the organizations (Research Division / Manufacturing Division) to ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic initiatives to advance functional impact. The applicant will also have experience in developing intermediate modalities like oligonucleotides and peptides and have an external network both across industry and academia. Maintaining a strong 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.
The incumbent will also be responsible for the recruiting, appraisal, and development of personnel under her/his supervision. The Director selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under her/his direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a proven track record of developing talent from a diverse scientific background and will have the ability to advance our company's commitment to a diverse and inclusive work environment.
Essential Knowledge, Duties & Responsibilities for the Director Include:
- Sterile drug product development concepts, tools, and requirements for all dosage forms (liquid, lyo, drug-device combinations)
- Review and approval of data and technical documents
- Ability to recruit, select, develop, and mentor talent
- Strategic and critical thinking to advance sterile product development strategy
- Project management skills
- Attention to technical detail
- Builds collaborations across internal departments and key stakeholders
- Ability to lead and champion organizational structure and be a change agent when necessary
- Developing the departmental budget and meeting the agreed upon spend
- Collaborates and builds strong relationships with upper management and other disciplines to select and qualify new CMOs/CROs/CDMOs
Qualifications:
Education:
- Ph.D. in chemical engineering, chemistry, pharmaceutical sciences, pharmaceutics, biochemical / biomedical engineering, or relevant field with minimum of 8+ years of industrial experience
- B.S. or M.S. in chemical engineering, chemistry, pharmaceutical sciences, pharmaceutics, biochemical / biomedical engineering, or relevant field with minimum of 10+ years of industrial experience
Required Experience and Skills:
- Relevant experience in pharmaceutical development with exposure to all stages and aspects of development (preclinical, clinical, and commercial) and cGMP industrial background
- Experience in developing sterile and specialty products (e.g. include long-acting injectable suspensions, implants, inhalation products, sterile liquid/ lyophilized products, and particle-based delivery systems). Knowledge of intermediate modality evaluations, delivery technology development, and understanding of parenteral formulation development.
- Experience with process design and/or scale-up in the clinical or commercial space, including process flow diagrams and engineering drawings
- Process development and technology transfer experience including the use of risk assessment and process capability (Ppk) tools. Demonstrated ability to identify, mitigate, and clearly articulate program risks.
- Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC, and demonstrated experience partnering for Pharmaceutical development / CMC with Quality, Regulatory, Operations, Non-clinical, Clinical, and other functional areas
- Experience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs
- Must be innovative and drive new ideas, but also have pragmatic approach to development options, technology selection, and regulatory posture
- Knowledgeable of the Capital Process having participated on a large capital project team, and exposure to project / engineering work process and deliverables (e.g. equipment fabrication, FAT, SAT, Validation etc.)
- Strong experience in safety and environmental knowledge and site presence
- Excellent verbal and written communication skills, demonstrated creativity, strong interpersonal and collaboration skills
- A strong track record of publications in parenteral drug product development and/or delivery
- Demonstrated ability to lead cross-functional teams with proven talent development skillsets
- Demonstrated strength in delivering results on firm deadlines in support of product discovery, process development, and commercial filings for biopharmaceuticals or vaccine products
Preferred Experience and Skills:
- Recognized expertise in novel delivery technologies (e.g. long-acting injectables, particle-based delivery systems) for small molecule or synthetic modalities for clinical and/or commercial manufacturing would be ideal
- Experience in regulatory compliance expectations across all phases of product development to commercialization
- Demonstrated leadership skills and organization design (i.e. building high performing teams, building talent, and shown to be able to motivate, influence scientific team; lead by example through past scientific / technical expertise).
- Experience in budget planning & management, establishing development strategies, and managing scientific staff from a budgetary and personnel decisions standpoint
- Experience in equipment Fabrication, FAT/SAT, start-up, qualification and/or validation is preferred
- Fill/finish process scale-up, Drug Delivery and/or technology transfer experience including the use of gap analysis and risk assessment tools
- Highly motivated, flexible, a change agent, and ability to work in a fast-paced environment
- Encourages innovative thinking / risk-taking and eliminates obstacles / barriers to implement change
- Ability to present clear and compelling quality and business cases. Ability to engage and align other stakeholders outside the project team.
- Ability to apply and promote a growth mindset with teams and partnerships.
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.
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 Rights
EEOC GINA 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.
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 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:
$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. 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 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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/8/2024
*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.
Requisition ID:R316589
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job Similar Jobs
