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Director of Chemical & Manufacturing Controls (CMC) job

Ovid TherapeuticsNew York, NY
Ovid Therapeutics jobs

Company

Salary

Skills

Job Description

SUMMARY: The Director of CMC is accountable for Manufacturing and Development efforts in leading the development of clinical through commercialization processes for API and Drug Product Manufacturing, Packaging, Labeling and Logistics. This position reports to the SVP of Regulatory, CMC & QA.RESPONSIBILITIES:Assertive "hands-on" CMC, working with Contract Manufacturing Organizations (CMOs) to develop production plans and provide technical support while ensuring timelines for clinical and commercialization efforts are met.Direct and manage the clinical supplies and logistics for Ovid in collaboration with Ovid Clinical Operations Team, CROs and CMOs for domestic and international trials. Including but not limited to: packaging configuration; labeling and label translation oversight.Work with CMOs in developing Manufacturing Processes and Analytical Methods.Provide recommendations, reviews and approvals of protocols, processes, batch records, stability studies and final reports.Participate in PAI Readiness activities.Act as Manufacturing Subject Matter Expert (SME) during regulatory inspections.Review investigations, change controls and CAPAs associated with manufacturing activities of Ovid products.Oversee and approve technical transfer of Ovid methods and processes.Support GMP efforts to ensure alignment with Regulatory requirements.Develop and negotiate Supply Agreements with CMOs for Ovid products.Oversee process validation where applicable.Develop or revise SOPs applicable to CMC by working with QA and Regulatory to ensure company policies are adhered to.Oversee CMOs comply with Ovid company policies and regulatory requirements.Prepare CMC regulatory filing sections (domestic and international) working with Regulatory and Quality.Establish CMC reports and provide updates to Senior Management.QUALIFICATIONS:Minimum Bachelor's degree in Chemistry or related Science. Advanced degree preferred.Minimum 10 years hands-on CMC and management experience with focus on manufacturing/quality/clinical from development through commercialization in the Pharmaceutical industry.Experience with oral solid and liquid dosage forms.Direct experience effectively managing API and Drug Product CMOs.Significant knowledge of GMP and FDA regulations related to CMC.Proficient in authoring and preparing CMC documentation for regulatory submissions.Strong knowledge of Clinical trials supplies management.Excellent interpersonal communication skills and be highly collaborative when interacting within and outside the organization.Demonstrated personal leadership and ability to effectively direct multiple projects with positive results within project timelines.May require both international and domestic travel, up to 15 percent. Equal Opportunity Employer/Veterans/Individuals w/Disabilities
Estimated annual salary
$123,393
average
Minimum
$106,525
Maximum
$160,738

TASKS

  • Review processing schedules or production orders to make decisions concerning inventory requirements, staffing requirements, work procedures, or duty assignments, considering budgetary limitations and time constraints.
  • Direct or coordinate production, processing, distribution, or marketing activities of industrial organizations.
  • Develop or implement production tracking or quality control systems, analyzing production, quality control, maintenance, or other operational reports to detect production problems.
  • Review operations and confer with technical or administrative staff to resolve production or processing problems.

SKILLS

  • Reading ComprehensionUnderstanding written sentences and paragraphs in work related documents.
  • Active ListeningGiving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
  • WritingCommunicating effectively in writing as appropriate for the needs of the audience.
  • SpeakingTalking to others to convey information effectively.

KNOWLEDGE

  • Administration and ManagementKnowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
  • ClericalKnowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
  • Customer and Personal ServiceKnowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
  • Personnel and Human ResourcesKnowledge of principles and procedures for personnel recruitment, selection, training, compensation and benefits, labor relations and negotiation, and personnel information systems.

Ovid Therapeutics

Type

Company - Public

Size

Small

Revenue

Less than $1M

Location

1460 BroadwayNew York, NY, 10036

Industry

Pharmaceutical/Bio-tech
Consulting/(Non-Executive) Management
Education/Training
More...

Founded

2014

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MANAGER, IT OPERATIONSOvid TherapeuticsNew York, NY
OVID Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicine® approach to develop medicines that transform the lives of patients with rare neurological disorders. We believe these disorders represent an...Read more
Sr. ParalegalOvid TherapeuticsNew York, NY
In this highly visible role, you will work in a dynamic, fast-paced environment and will have the opportunity to work independently and as part of a legal team, that provides crucial support to the company as a whole. You must be able to adapt to changing...Read more
The Associate Director, Payroll Equity & Benefits is the go to person for anything regarding payroll and the financial side of benefits administration. This Ovidian ensures that employees are paid correctly and on time and their benefits are in sync with...Read more
Executive Assistant to the Head of R&DOvid TherapeuticsNew York, NY
In this highly visible role, the Executive Assistant provides administrative support to the Head of Research & Development, as well as leaders in the R&D department.Responsibilities:Ensure that Ovid Therapeutics' s mission and values are understood and...Read more
Research Associate, NeurobiologyOvid TherapeuticsCambridge, MA
OVID Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicineA approach to develop medicines that transform the lives of patients with rare neurological disorders. We believe these disorders represent an...Read more

Closed Job Filters

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Director of Market AccessOvid TherapeuticsNew York, NY
OVERVIEW Ovid is looking for a passionate, dynamic and collaborative individual to lead global market access for our phase 2 rare epilepsy asset, soticlestat which is being co-developed with Takeda.Read more
Director of Market AccessOvid TherapeuticsNew York City, NY
OVERVIEW Ovid is looking for a passionate, dynamic and collaborative individual to lead global market access for our phase 2 rare epilepsy asset, soticlestat which is being co-developed with Takeda.Read more
PATIENT ADVOCACY MANAGEROvid TherapeuticsNew York, NY
ROLE The Patient Advocacy Manager enhances our engagement with the patient community and is key to our mission at Ovid Therapeutics to build strong relationships with the patient community. TheRead more
Patient Advocacy ManagerOvid TherapeuticsNew York City, NY
ROLE The Patient Advocacy Manager enhances our engagement with the patient community and is key to our mission at Ovid Therapeutics to build strong relationships with the patient community. TheRead more
Patient Advocacy ManagerOvid TherapeuticsGreeley Square, NY
ROLE The Patient Advocacy Manager enhances our engagement with the patient community and is key to our mission at Ovid Therapeutics to build strong relationships with the patient community. TheRead more
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