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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.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 is fast paced and 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 vision to develop a team, demonstrated leadership skills, critical thinking, effective technical and communication skills, effective understanding of the regulatory environment, and vision to influence the regulatory environment.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, 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
#AR&DWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.Who we are …We are known as Merck & Co., Inc., Rahway, 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 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.Residents of ColoradoClick here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.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 health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA SupplementOFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf)Pay 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Residents of Colorado:Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.Search Firm Representatives Please Read CarefullyMerck & 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:DomesticVISA Sponsorship:YesTravel Requirements:10%Flexible Work Arrangements:Shift:1st - DayValid Driving License:Hazardous Material(s):Number of Openings:2Requisition ID: R202940
Vacancy expired!