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.

Overview

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.

Responsibilities

--- 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.

Qualifications

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.

PI

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