Senior Director of Process Chemistry- Manufacturing, Science & Technology-(MS&T)
Company: Phlow Corp.
Location: Richmond
Posted on: March 20, 2023
Job Description:
The---purpose of this role is to---manage partner Contract
Development Manufacturing Organizations (CDMOs) to ensure excellent
Active Pharmaceutical Ingredients (API)---manufacturing process
development, technical transfer, validation and commercial
manufacture of Phlow's target APIs, and to drive continuous
improvement, when appropriate. The candidate will be a
partner-facing---leader who personifies Phlow's shared values and
culture, both internally and externally.---This role's
scope---spans---from process design and development through
manufacturing and regulatory submission.---The candidate---will
work with the highest standards of integrity, transparency, and
ethics to create win-win scenarios for patients, customers,
partners, and colleagues.--- -Responsibilities:------ -
- Manage R&D development partners to ensure a scalable,
cost-competitive manufacturing process is developed on time, on
budget and ready for technology transfer to manufacturing partners
-
- Manage manufacturing partners to ensure that manufacturing
processes are successfully validated and product manufactured on
time and on budget -
- Review, author and approve manufacturing process documentation
such as process development protocols and reports, batch records,
validation protocols and reports, specifications, etc. - -
- Contribute to the timely and accurate preparation of regulatory
submissions - -
- Supervise the ongoing continuous improvements in manufacturing
processes resulting in improving product quality, robustness, and
cost -
- Manage multiple projects/workstreams and make sound and timely
decisions based on business priorities -
- Assist as a process chemistry SME for CRO/CDMO/CMO audits
-
- Collaborate with Project Management, Analytical Chemistry,
Quality Assurance, Regulatory Affairs, and Engineering to ensure
strong working relationships with all partners and Phlow
employees------ -Qualifications:------ -
- Minimum of---10 years working in related roles in the
pharmaceutical industry demonstrating
increasing---responsibility------ -
- Strong track record of success---including process development,
technology transfer, and continuous improvement------ -
- Strong interpersonal and communication skills---------
----Preferred Qualifications:------ -
- PhD (or equivalent based upon work experience) in Organic
Chemistry, Pharmaceutical Sciences or a related scientific field
-
- Significant process chemistry and API manufacturing experience
on multi-kilogram scale -
- Experience with generic API development, technology transfer
and manufacture -
- Knowledge of ICH and cGMP requirements -
- Experience managing third-party vendors (CROs/CMOs/CDMOs)
-
- Experience with technical and operational risk assessments
(e.g., process robustness, mutagenic impurities, nitrosamines,
etc.) -
- Experience with design of experiments (DOE) and related
multivariate experimentation approaches -
- Experience with the development and implementation of
continuous flow manufacturing processes is a plus -
- Experience authoring or contributing to regulatory submissions
(NDAs/ANDAs/DMFs) -About Phlow: - Phlow Corp. ("Phlow") is a public
benefit essential medicine manufacturing company dedicated to
reliably supplying affordable, high-quality, essential medicines
through U.S. based advanced manufacturing processes. The company
manufactures precursor chemical ingredients, active pharmaceutical
ingredients (API), and finished pharmaceutical products,
domestically for essential medicines critical to the Nation's
healthcare. To help ensure the quality, safety, and affordability
of pharmaceutical products of strategic importance to the United
States, Phlow utilizes advanced manufacturing platforms, including
continuous manufacturing, to provide essential medicines to its
customers, health systems, and government partners. - - - -
-Phlow's commitment to diversity includes recognition that our
mission is best advanced by the leadership and contributions of
colleagues of diverse backgrounds, beliefs, and culture. Recruiting
and mentoring staff to create an inclusive organization that
reflects our shared values is a priority. - -Corporate Social
Responsibility: At Phlow, we recognize and put great value in our
responsibility to all of our stakeholders. This is why Phlow pays
attention to the triple bottom line, which considers social,
environmental, and financial sustainability. Team members are
expected to understand these concepts and consider the triple
bottom line in daily decision making. - - -EEO Statement: - - Phlow
provides equal employment opportunities (EEO) to all employees and
applicants for employment without regard to race, color, religion,
gender, sexual orientation, gender identity, national origin, age,
disability or genetics. In addition to federal law requirements
Phlow complies with applicable state and local laws governing
nondiscrimination in employment in every location in which the
organization has facilities. This policy applies to all terms and
conditions of employment, including recruiting, hiring, placement,
promotion, termination, layoff, recall, transfer, leaves of
absence, compensation and training. - - -At Phlow, we are committed
to our people. We strive to create a best workplace in the world
through providing world class benefits and creating a culture
around our shared values. We are proud to be a certified Great
Place to Work. Find out more about what makes Phlow a great place
to work - -Powered by JazzHR
Keywords: Phlow Corp., Richmond , Senior Director of Process Chemistry- Manufacturing, Science & Technology-(MS&T), IT / Software / Systems , Richmond, Virginia
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