LakewoodNJRecruiter Since 2001
the smart solution for Lakewood jobs

Sr. Manager, Formulation Research & Development

Company: Renaissance LLC
Location: Lakewood
Posted on: February 20, 2021

Job Description:

Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.


The Sr. Manager of Formulation Research and Development is the lead scientific technical role within Formulation Research and Development. This role manages and leads the formulation team involved in formulation development and technology transfer to the manufacturing site, troubleshoots manufacturing challenges and supports formulation aspects of regulatory submissions for CDMO clients. This role must ensure development of manufacturing processes that can be scaled to commercial size, propose finished product specifications, author technical reports, review documents related to product development aspects of CMC section of the FDA submission (and other regulatory authorities as needed). The candidate will mentor and train senior and junior scientists. This individual will also interact frequently with Quality, MS&T, Operations, Sales, Business Development and Regulatory Affairs and Quality Compliance teams. This role interfaces with all clients and provides technical expertise on pre-formulation, formulation and technical formulation challenges. The majority of this role is to keep the CDMO formulation client's needs at the forefront, interfacing with clients to offer solutions and services. A small portion of the role may include some intellectual property that compliments the business goals as described below. This position is exempt from overtime.


--- Manages formulation and manufacturing development activities for pharmaceutical products including nasal and injectable products for all new CDMO projects. Familiarity with the device(s) for nasal and injectables, as applicable, is a plus to assist in development issues that can come from the device. Familiarity with complex formulations, including peptides and proteins, as well as, appropriate ways to chararacterize these molecules is a plus.
--- Understand overall drug development process, regulatory guidelines, and CMC strategy in US, with global experience a plus.
--- Build a proof of concept formulation from other dosage forms to assist in readying other market platforms, as needed and only after the Executive Team grants approval to start.
--- Partner well with the head of MS&T to provide formulations that scale on the commercial equipment.
--- Assist in building/growing a pilot formulation R&D facility as needed.
--- Provide a toolkit of excipients and packaging component interactions that might eventually lead to intellectual property for the Company, only as needed and only after Executive sign-off of all work outside client funded work.
--- Research and propose to the Executive Team what technology might be needed for future products (e.g. lyophilizer, etc.).
--- A majority of this role requires maintaining good relationships with our clients and partnering with them to solve already existing issues. Propose solutions to new issues that arise during the development and/or scale up process.
--- Prepare and review project protocols, assess and identify deliverables.
--- Review technical data, documents and proposals. Lead and manage the writing of protocols and
technical reports as needed.
--- Manage department resources (personnel and budget) to meet R&D objectives.
--- Manage costing and budgets, along with Project Management, to ensure all work performed is covered under a paid protocol.
--- Provide technical expertise and guidance to senior and junior scientific staff.
--- Ensure that adequate project resources are available, including personnel, equipment, supplies, and facilities.
--- Develop and manage personnel in support of talent management and succession planning programs.
--- Identify, develop, and foster good working relationships with external customers and support initiatives required to continually enhance Renaissance reputation with customers.
--- Act as scientific liaison for all client calls regarding formulation.
--- Create, review and approve product development reports as needed.
--- Understand and comply with all Renaissance safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
--- Ensure all department SOPs are in place and adhered.


PhD degree with 5 years of relevant experience in the pharmaceutical industry and a proven record of achievement is required. Experience leading an R&D group is preferred. A proven track record of reverse engineering formulations is required. Knowledge of nasal and injectable formulations a must.


Keywords: Renaissance LLC, Lakewood , Sr. Manager, Formulation Research & Development, Executive , Lakewood, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Director of Human Resources
Description: If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you will find the contact information to request the appropriate accommodation by visiting (more...)
Company: Crescent Hotels & Resorts
Location: White Plains
Posted on: 02/25/2021

Case Management Travel RN - Job Id: JO02986366
Description: Medical Staffing Options is seeking a qualified
Company: Medical Staffing Options
Location: White Plains
Posted on: 02/25/2021

Vice President Commercial Lending
Description: Magyar Bank, a leader in the community banking sector, is searching for qualified candidates to join our Compliance team as a Vice President, Commercial Lending in New Brunswick, New Jersey.Position Summary:This (more...)
Company: Magyar Bank
Location: New Brunswick
Posted on: 02/25/2021

Community School Director
Description: FHI 360 is seeking an innovative professional for the role of Community School Director to organize and support the day-to-day responsibilities of implementing a community school model at David Paterson (more...)
Company: FHI 360
Location: Hempstead
Posted on: 02/25/2021

Cost Accounting Manager
Description: Job SummaryResponsible for gathering, analyzing and reporting all aspects relating to Plant Finance. The person will support activities of multiple locations in New Jersey.Area of ResponsibilityManage (more...)
Company: ProStaff Solutions
Location: New Brunswick
Posted on: 02/25/2021

Director, Salesforce Development
Description: Job Description - Director, Salesforce Development 21000212 Job Description Description Are you highly motivated, detailed oriented and passionate about preparing for your career Then we are looking (more...)
Company: CTI Education Group
Location: White Plains
Posted on: 02/25/2021

Description: Level Experienced Job Location New Brunswick, NJ - New Brunswick, NJ Position Type Full Time Graduate Degree Salary Range Undisclosed Travel Percentage Up to 50 Job Shift Undisclosed Job Category Biotech (more...)
Company: Caris Life Sciences
Location: New Brunswick
Posted on: 02/25/2021

Associate Director, Digital Capability Management , PD Systems
Description: Associate Director, Digital Capability Management , PD Systems New Brunswick - NJ - US At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.--In oncology, (more...)
Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: 02/25/2021

Regional Manager
Description: Come Join Our Team Now Hiring Regional Manager Essex County, NJCompany OverviewIt is our belief that the delivery of hospice care can be taken to a new level of excellence by those who understand the (more...)
Company: Grace Healthcare Services
Location: West Orange
Posted on: 02/25/2021

Regional Director of Resident Services
Description: Regional Director of Resident Services - CT The Regional Director of Resident Services RDRS , along with the Executive Director and Resident Services Director RSD is responsible for overseeing the (more...)
Company: Maplewood Senior Living
Location: Westport
Posted on: 02/25/2021

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Lakewood RSS job feeds