Sr. Manager, Formulation Research & Development
Company: Renaissance LLC
Posted on: February 20, 2021
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
--- 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
--- 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
--- 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
--- 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
--- 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
--- Create, review and approve product development reports as
--- 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
Keywords: Renaissance LLC, Lakewood , Sr. Manager, Formulation Research & Development, Executive , Lakewood, New Jersey
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