Jobs
>
Richmond

    Director of Process Chemistry - Richmond, United States - Phlow Drug Products

    Phlow Drug Products
    Phlow Drug Products Richmond, United States

    1 week ago

    Default job background
    Description
    Apply

    Job Type

    Full-time

    Description

    Job Overview


    The purpose of this role is to provide Subject Matter Expertise (SME) in the area of process chemistry and to perform and direct process development in Phlow's Advanced Manufacturing R&D lab.

    The Director, Process Chemistry will support the CDMO business to ensure business objectives are met and for execution of the internal Phlow API development projects.

    Serve as the technical leader for the development and scale-up of new processes for the synthesis of active pharmaceutical ingredients.

    The candidate will plan, organize, perform and oversee process chemistry activities in the Phlow Advanced Manufacturing R&D lab to ensure that timelines, specifications, cGMP requirements, in addition to other elements of contracts, are realized.

    The candidate will ensure excellence of our process development and technical transfer to Phlow's partners or customers and interact with other internal and external Phlow departments (EH&S, Engineering, Program Management, Quality Assurance, Regulatory Affairs) as required.

    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 subject matter expertise to support Phlow's Advanced Manufacturing CDMO business.
    • Plan, organize, perform and oversee process chemistry activities.
    • Ensure the deliverables to customer's projects are met on time and on budget.
    • Work with customers for efficient technology transfers.
    • Manage a team of process chemists within the Phlow Advanced Manufacturing R&D lab.
    • Assist in screening, interviewing, and selecting qualified candidates for open positions within the department.
    • Evaluate new projects with the department to identify synthetic routes for process development that deliver scalable, cost-competitive manufacturing process that are ready for technology transfer to manufacturing partners for internal projects.
    • Conduct literature searches and laboratory work to identify potential synthetic routes and propose optimal routes for evaluation and development.
    • Review, author and approve documentation such as process development protocols and reports, batch records, validation protocols and reports, specifications, etc.
    • 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.
    Requirements



    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.
    • Extensive understanding of the business principles of a CDMO or like environment.
    • Excellent 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.
    • Significant experience with generic API development, technology transfer, and manufacture.
    • Knowledge of ICH and cGMP requirements.
    • Experience working for a contract organization (CROs/CMOs/CDMOs)
    • Experience managing third-party vendors (CROs/CMOs/CDMOs).
    • A track record of speaking at conferences and publishing in peer reviewed journals.
    • 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 authoring or contributing to regulatory submissions (NDAs/ANDAs/DMFs).
    • Experience with the development and implementation of continuous flow manufacturing processes is a plus.
    Physical Requirements


    • Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
    • Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
    • Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
    • Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
    • Occasionally lift and/or move up to 10 pounds.
    • This position may require up to 10% to 25% travel with occasional increase in travel demands based on business needs.
    • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Phlow Corp

    Director of Process Chemistry

    2 weeks ago

    Phlow Corp Richmond, United States

    Job Overview · The purpose of this role is to provide Subject Matter Expertise (SME) in the area of process chemistry and to perform and direct process development in Phlow's Advanced Manufacturing R&D lab. The Director, Process Chemistry will support the CDMO business to ensure ...

  • Phlow Corporation

    Director of Process Chemistry

    6 days ago

    Phlow Corporation Richmond, United States

    Job Description · Job DescriptionDescription: Job Overview · The purpose of this role is to provide Subject Matter Expertise (SME) in the area of process chemistry and to perform and direct process development in Phlow's Advanced Manufacturing R&D lab. The Director, Process Chemi ...

  • Phlow Corp

    Director of Process Chemistry

    1 week ago

    Phlow Corp Richmond, United States

    Job Overview · The purpose of this role is to provide Subject Matter Expertise (SME) in the area of process chemistry and to perform and direct process development in Phlow's Advanced Manufacturing R&D lab. The Director, Process Chemistry will support the CDMO business to ensure ...

  • Carpenter Co.

    Group Leader, Polyol Applications

    3 days ago

    Carpenter Co. Richmond, United States

    Do you want to be part of a team that aspires to improve the quality of life for others? Are you interested in efficient manufacturing processes that promote sustainability? Do you feel a sense of accomplishment in a job well done? At Carpenter Co., we challenge our employees to ...

  • Actalent

    Lab Technician

    11 hours ago

    Actalent Richmond, United States Full time

    Description: · The individual filling this position will be responsible for operating the instruments used to perform the initial analysis on urine and oral specimens for substances of abuse. · • Advanced ability to understand analytical techniques and procedures. (GC-MS, LC-MS, ...

  • Carpenter Co.

    Research Chemist

    3 days ago

    Carpenter Co. Richmond, United States

    Do you want to be part of a team that aspires to improve the quality of life for others? Are you interested in efficient manufacturing processes that promote sustainability? Do you feel a sense of accomplishment in a job well done? At Carpenter Co., we challenge our employees to ...

  • Actalent

    PFAS Lab Manager

    11 hours ago

    Actalent Richmond, United States Full time

    Description: · • Write, review and approve analytical methods, protocols, procedures, reports, COAs and other documents. · • Conduct validation of analytical methods. · • Monitor QA/QC acceptance criteria for sample results and instrument calibrations per method SOPs equipment an ...

  • AdvanSix

    Safety Specialist

    4 hours ago

    AdvanSix Richmond, United States

    Why work at AdvanSix? · - We provide benefits that are industry competitive and focused on employee well-being · - Total Rewards program includes a competitive compensation, health, dental, vision & wellness programs, paid vacation, 401K with company matching, health savings prog ...

  • AdvanSix

    Nylon Capital Leader

    4 hours ago

    AdvanSix Richmond, United States

    Why work at AdvanSix? · - We provide benefits that are industry competitive and focused on employee well-being · - Total Rewards program includes a competitive compensation, health, dental, vision & wellness programs, paid vacation, 401K with company matching, health savings prog ...

  • HCA Healthcare

    Microbiology Technician Prn

    1 week ago

    HCA Healthcare Richmond, United States

    **This is a PRN, as needed position.**: · Last year our HCA Healthcare colleagues invested over 156,000 hours volunteering in our communities. As a Microbiology Technician PRN with HCA Healthcare you can be a part of an organization that is devoted to giving back · **Benefits**: ...

  • HCA Healthcare

    Microbiology Technician

    1 week ago

    HCA Healthcare Richmond, United States

    **This is a full time, night shift position with rotating weekends**: · Last year our HCA Healthcare colleagues invested over 156,000 hours volunteering in our communities. As a Microbiology Technician with HCA Healthcare you can be a part of an organization that is devoted to gi ...

  • HCA Healthcare

    Microbiology Manager

    1 week ago

    HCA Healthcare Richmond, United States

    This position is incentive eligible. · **$10,000 Sign On Bonus Offered**: · **Introduction** · Do you have the career opportunities as a Microbiology Manager you want with your current employer? We have an exciting opportunity for you to join HCA Healthcare which is part of the n ...

  • Triple-S Steel

    Inside Sales Representative

    1 week ago

    Triple-S Steel Richmond, United States

    At Triple-S Steel we live and work by our core values. Since our inception over 50 years ago, we have followed three basic principles that are the foundation of our success: · **Stability**: All decisions made are measured in years, not quarters. · **Flexibility**: Employees are ...

  • Actalent

    Chemist

    2 days ago

    Actalent Chesterfield, United States Full time

    Description: · Evaluates the chemical and physical properties of various organic and inorganic substances to investigate their applications in formulated products. · Has knowledge of commonly used physical chemistry concepts, practices, and procedures within a particular field. · ...

  • Phlow Drug Products

    Principal Chemist

    1 week ago

    Phlow Drug Products Richmond, United States

    Apply · Description · The Principal Chemist will possess an in-depth knowledge of process chemistry skills for the development of synthetic routes for drug substances. The candidate will perform multi-step chemical syntheses and product isolation/purification operations in the la ...

  • State of Virginia

    Postdoctoral Position

    5 days ago

    State of Virginia Richmond, United States

    of the Job: · A postdoctoral position in bioinorganic chemistry is available for a skilled and enthusiastic chemist within the multidisciplinary Lucas Labs at Virginia Commonwealth University in Richmond ( ). The principal research topic will be centered around the elucidation o ...

  • State of Virginia

    Postdoctoral Position

    1 week ago

    State of Virginia Richmond, United States

    of the Job: · The Lucas Lab ( ) within the Department of Chemistry at Virginia Commonwealth University has an NIH-funded postdoctoral position available for an enthusiastic and skilled scientist. Candidates with expertise in the biochemical and biophysical characterization of pr ...

  • Phlow Corporation

    Principal Chemist

    6 days ago

    Phlow Corporation Richmond, United States

    Job Description · Job DescriptionDescription:The Principal Chemist will possess an in-depth knowledge of process chemistry skills for the development of synthetic routes for drug substances. The candidate will perform multi-step chemical syntheses and product isolation/purificati ...

  • Yoh

    Analytical Chemist I, Quality

    1 week ago

    Yoh Richmond, VA, United States

    Analytical Chemist needed for a contract opportunity with Yoh Scientific's client located in Richmond, Virginia. · This position is for a major pharmaceutical company and requires a Bachelor of Science degree in an applicable scientific discipline with at least 3 years of experi ...

  • Bon Secours Mercy Health

    Histology Laboratory Supervisor

    1 week ago

    Bon Secours Mercy Health Richmond, United States

    At Bon Secours Mercy Health, we are dedicated to continually improving health care quality, safety and cost effectiveness. Our hospitals, care sites and clinicians are recognized for clinical and operational excellence. · **Summary of Primary Function/General Purpose of Position ...