Manager Process Chemistry, Manufacturing, Science & Technology (MS&T)

Richmond, VA
Full Time
Mid Level

The purpose of this role is to provide process chemistry support to Phlow’s Continuous Manufacturing R&D lab.  The Manager, Process Chemistry will design, synthesize, purify, and analyze chemical intermediates and target compounds under the direction of the Director, Process Chemistry.  The candidate will support the CDMO business to ensure business objectives are met and for the execution of the internal Phlow API development projects.  The candidate will ensure the excellence of our process development and technology transfer to Phlow’s partners or customers. The candidate will personify Phlow’s shared values and culture, both internally and externally. The candidate will work with the highest standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues. 

 

Responsibilities:  

  • Provide process chemistry support to Phlow’s Continuous Manufacturing R&D lab to ensure the deliverables to customers' projects are met on time and on budget and to ensure a scalable, cost-competitive manufacturing process is developed on time, on budget, and ready for technology transfer to manufacturing partners for internal projects.
  • Design, synthesize, purify, and analyze chemical intermediates, target compounds, and impurities.
  • Author progress reports and present scientific results to team members.
  • Support Phlow’s manufacturing partners during product manufacturing and validation campaigns.
  • Contribute to the timely and accurate preparation of regulatory submissions.
  • Participate in 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.
  • Collaborate with Analytical Chemistry, EH&S, Engineering, Project Management, Quality Assurance, and Regulatory Affairs to ensure strong working relationships with all partners and Phlow employees.

 

Qualifications:  

  • Minimum of 5 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.
  • Process chemistry and API manufacturing experience on a multi-kilogram scale.
  • Experience with generic API development, technology transfer and manufacture.
  • Understanding of the business principles of a CDMO or like environment.
  • Knowledge of ICH and cGMP requirements.
  • Experience managing third-party vendors (CROs/CMOs/CDMOs) is a plus.
  • Experience with technical and operational risk assessments (e.g., process robustness, mutagenic impurities, nitrosamines, etc.) is a plus.
  • 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) is a plus.

 

Share

Apply for this position

Required*
Apply with Indeed
We've received your resume. Click here to update it.
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.

Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status



Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 5/31/2023
Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date