Associate Director, External Drug Product Manufacturing

Celldex Therapeutics, Inc.; Hampton, Northern (VA, KY); Hybrid; USD 154,000 - 200,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking an Associate Director, External Drug Product Manufacturing to oversee aseptic filling demands at CMOs and manage budgets in line with cGMP standards.

The role requires coordinating with clinical and commercial teams, approving invoices, reviewing batch records, and guiding investigations of excursions to prevent recurrence. Candidates should have a Bachelor’s or Master’s in Engineering or Biological Sciences, 5–8 years of experience, and travel up to 20%.

Qualifications

• Bachelor’s or Master’s degree in Engineering or Biological Sciences.
• 5-8 years’ experience managing aseptic drug filling operations at CMOs or in-house.
• Experience managing internal resources and external contractors/vendors.
• Knowledge of secondary packaging operations.
• Strong communication and organizational skills.
• Project Management Certification.
• 10-20% domestic and international travel required.

Responsibilities

• Provide oversight as person-in-plant (PIP) for Drug Product fills at CMOs.
• Lead CMOs by providing forecasts and quotations for drug product manufacturing operations.
• Liaise with clinical and commercial teams to create product forecasts.
• Investigate and onboard new Drug Product Manufacturing CMOs.
• Review invoices and batch records.
• Review excursions or deviations during shipment, handling, and storage; drive investigations to resolution with Quality, CDMO and clinical sites.

Skills

Project management

Communication

Team player

Budget analysis

Problem solving

Interpersonal skills

Process improvement

Education

Bachelor’s or Master’s degree in Engineering or Biological Sciences

Tools

MS Office

MS Project

Excel

PowerPoint

Job description

Overview

This position of Associate Director, External Drug Product Manufacturing will oversee on-going and new drug product aseptic filling demands at Contract Manufacturing Organizations (CMO’s) and budget management while adhering to Good Manufacturing Practices, company policies and procedures. This individual shall support the Contract Manufacturing Organization providing oversight of aseptic drug product manufacturing.

Responsibilities

• Provide oversight as person-in-plant (PIP) For Drug Product fills at CMOs.
• Lead CMO’s by providing forecasts, requesting quotations for drug product manufacturing operations.
• Liaise with the clinical teams and commercial teams to create product forecasts.
• Investigate and onboard new Drug Product Manufacturing CMO’s.
• Review and approve invoices.
• Review master and executed batch records.
• Review excursions or deviations that may occur during shipment, handling, and storage of drug products. Drive such investigations to resolution in collaboration with Quality, CDMO and clinical sites and define and implement procedures to minimize future occurrences.

Qualifications

• Bachelor’s or Master’s degree in Engineering or Biological Sciences.
• 5-8 years’ experience in managing aseptic drug filling operations at CMO’s or in-house.
• Experience managing internal resources and external contractors/vendors.
• Knowledge of secondary packaging operations.
• Interpersonal skills to effectively manage internal and external communications.
• Analyze inventory, forecasts and budget spreadsheets.
• Project management skills
• High level of competence in aseptic Drug Product biopharmaceutical manufacturing of vials and pre-filled syringes.
• Knowledge of biopharmaceutical quality standards, validation guidelines and regulatory compliance issues
• Strong experience writing and implementing batch records and SOPs in a cGMP environment.
• The ability to work with long term planning and development of capital requests.
• Strong communication and organizational skills.
• Team player with demonstrated ability to prospectively identify issues and to influence key project decisions to achieve positive outcomes.
• Project Management Certification
• Proficient in the use of MS Outlook, Word, Excel, Power Point, Project
• 10-20% domestic and international travel required

Compensation Statement

The expected base salary for this position is: $153616.00 to $199501.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.