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Director, API Development

DirectorDirectorFull TimeRemoteSeniorTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

94 days ago

Salary

$220K - $240K / year

Seniority

Senior

Postgraduate Degree8 yrs expExperience acceptedEnglish

Job Description

Director, API Development

Celcuity

• Provide leadership and technical guidance for selection, transfer, and management of new CDMO manufacturing activities. • Lead current drug substance manufacturing process and optimize for continuous improvement of material. • Support ongoing CDMO manufacturing activities and troubleshoot issues and non-conformities. • Determine and resolve gaps for regulatory compliance with drug substance manufacturing and development. • Support formulation development with drug substance optimization, impurity identification, and pre-clinical study coverage involvement. • Author and review drug substance IND-enabling protocols, reports, and regulatory submissions. • Engage and support formulation development with new entity optimization and synthetic route creation/advancement. • Produce intellectual patent assessments and complete development projects intended for furthering IP generation. • Other duties as assigned.

Job Requirements

  • PhD, Master’s, or Bachelor’s degree in a physical science field, ideally chemistry, chemical engineering, or biomanufacturing.
  • ≥ 8 years in small molecule medicinal chemistry, API development, and/or manufacturing.
  • Experienced with early development activities including IND-enabling development and authoring.
  • Managed CDMOs for initial development, manufacturing, process validation, and transfer activities.
  • Knowledge of analytical technologies including LC, GC, NMR, MS, XRPD, and other relevant methodologies used for elucidation and purity determination.
  • Well-informed of FDA, EU, and ICH guidelines for drug substance manufacturing and quality assurance.
  • Excellent written and verbal communication skills, with ability to influence and build credibility at all levels.
  • Strong interpersonal skills for interacting with employees and leaders across various levels and functions.
  • Attention to detail and ability to manage multiple processes and documentation requirements.
  • Highly organized with documentation associated with project planning, communication, and resulting reports.
  • Strong technical and analytical skills with advanced knowledge in ChemDraw, and MS Office including Word, Excel, and PowerPoint.
  • Ability to work in a team or independently as required.
  • Outstanding organizational skills with the ability to prioritize.
  • Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
  • Maintain a positive, approachable and professional attitude.

Benefits

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k) match
  • Paid time off
  • Paid holidays
  • Annual performance incentive bonus
  • New hire equity package

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