Drug Product Job Description
Drug product
provides quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
Drug Product Duties & Responsibilities
To write an effective drug product job description, begin by listing detailed duties, responsibilities and expectations. We have included drug product job description templates that you can modify and use.
Sample responsibilities for this position include:
Provide technical leadership for formulation and drug product development activities including life cycle management projects
Minimum of 2 years for MS, Minimum of 4 years of experience for MS in biologics formulation/process development and manufacturing is required
Provide regulatory filing support for drug product (IND, BLA, MAA, ) support during regulatory inspection of site quality systems
Oversee and manage all clinical fill/finish activities to achieve set KPI's and drive continuous efficiency and improvement across all drug product CMO operations
Lead business review meeting with the CMOs and manufacturing partners
Actively participate in the Clinical Supply and Operations Planning process
Provide management for all development projects to ensure robust technical transfers and preparedness towards validation and product approval
Support all due diligence activities as needed to ensure practical assessment and recommendations, especially focus on novel technologies for Shire
Core team member for Drug and Combination Product Development Leadership Team (DCPD LT) - lead projects from time to time and drive overall LT priorities while delivering integrated PD / CMC support
Review and approves Corrective and Preventive Actions (CAPA)
Drug Product Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Drug Product
List any licenses or certifications required by the position: PMP, APICS, EHS, REACH, PHD, STEM, QP, CMO, CAPM, MPS
Education for Drug Product
Typically a job would require a certain level of education.
Employers hiring for the drug product job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Chemistry, Manufacturing, Science, Biology, Biochemistry, Chemical Engineering, Life Sciences, Pharmacy, Technical
Skills for Drug Product
Desired skills for drug product include:
EU
Quality systems
Industry practices and regulations
Written and spoken English
Nucleic acid chemistry and biology
Current US
Global Regulations
ICH guidance and relevant standards and quality system requirements for biological product manufacturing
Formulation
CGMP regulations pertinent to the USA
Desired experience for drug product includes:
10+ years in manufacturing, development, or comparable experience
Regulatory and compliance background, hands on technical transfer experience, and CMO (Contract Manufacturing Organization) selection & management expertise required
Some travel will be required for business meetings with vendors/contractors, and to stay current with professional development opportunities
Extensive experience in pharmaceutical development and parenteral manufacturing
Drug Product Development experience that spans early through late phase is required
Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance manufacturing
Drug Product Examples
1
Drug Product Job Description
Job Description Example
Our innovative and growing company is hiring for a drug product. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for drug product
- Work in a multidisciplinary, cross-functional environment and provide automation and controls expertise to support various control systems, for continuous solid oral dosage manufacturing operations
- Closely manage the development & commissioning of a next generation continuous manufacturing control system being developed by an external vendor
- Work together with internal and external stakeholders to provide technical support in maintaining, troubleshooting and optimizing control systems for multiple commercial continuous tableting plants
- Manage software validation activities including reviewing/authoring associated documentation such as user requirements, functional specifications, IQ/OQ protocols, testing plans, test scripts and summary reports
- Interface with process experts to gain detailed knowledge of the manufacturing process requirements and translate them to make improvements to control system logic
- Distill complex technical and automation problems down to their most basic components so that non-programmers can grasp key concepts
- Develop and maintain an effective organization
- Recognize development needs and create development opportunities within the team
- Coordinate the manufacture of drug product non-clinical and clinical batches
- Mentoring and supervising junior scientist in the department
Qualifications for drug product
- Knowledgeable of Elsevier products including CPi, GSDD, Clinical Pharmacology
- International and domestic travel will be required for business meetings with vendors/contractors, and to stay current with professional development opportunities
- Strong manufacturing experience and technical understanding across multiple technologies
- Physical Demands / Surroundings - The duties of this position may require the incumbent to exert some physical effort
- Must be able to independently represent the department in a wide-assortment of situations
- Must have experience ensuring respectful interactions with individuals with diverse views or backgrounds
2
Drug Product Job Description
Job Description Example
Our company is growing rapidly and is hiring for a drug product. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for drug product
- Prepare quarterly and annual forecasts to support senior management of Drug Product and provide financial basis for investor guidance
- Provide leadership for business development organization as far as pricing, revenue recognition, contract negotiation/analysis for the Drug Product business
- Providing technical oversight to third party CMOs in the routine manufacturing and packaging of Lexicon’s commercial products
- Preparing or reviewing protocols, batch records, memos, reports, regulatory documents, SOPs, and other policies as necessary
- Providing technical support to Lexicon’s quality organization and the third party CMO sites during significant manufacturing process technical investigations
- Supporting third party CMOs during trouble shooting and resolution of manufacturing related issues
- Recommending and supporting manufacturing process improvements to drive down cost and reduce waste in the manufacturing process
- Leading or providing technical support during technology transfer activities of a new or existing molecule from one third party CMO to another
- Providing technical leadership in monitoring and maintaining project timelines to meet business needs
- Providing technical oversight to third party CMOs in the routine manufacturing and packaging of Lexicon commercial product and ensuring that the drug product manufacturing is in control or capable by monitoring the critical quality attributes of each drug product and in process parameters
Qualifications for drug product
- BS/BA in engineering, materials science, physical or biological sciences or business with 4 years industry experience
- Master degree in Pharmaceutical Science or equivalent
- Demonstrated ability to coordinate and track activities
- Skilled at writing and reviewing technical documents CTD
- Proficiency with Quality by Design (QbD) concepts, statistical process control (SPC) and complex data analysis
- Experience with biologic's and/or inhalation products is a definite plus
3
Drug Product Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of drug product. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for drug product
- Providing technical support to Lexicon’s quality organization and the third party CMO sites in significant manufacturing process technical investigations and be able to support the third party CMO to trouble shoot and resolve manufacturing related issues
- Functions effectively as a core team member on multiple concurrent projects and may lead small projects
- Prepares, presents, and defends scientific data within and outside of Technical R&D
- Lead process improvement, trouble-shooting and manufacturing support
- Identify and analyze complex technical problems and then find and implement solutions
- Apply fundamental scientific and biological principles to practical technical challenges
- Work closely with his/her supervisor and coworkers in managing multiple work streams and projects
- Provide expert input to departmental and senior management towards making strategic & functional decisions based on project priorities
- Represent manufacturing and technical community on Technical Product Teams (TPT)
- Represent site capability/requirements to the product TPT
Qualifications for drug product
- Preference will be given to candidates who are knowledgeable over a broad range of skills described above rather than deep mastery in any single skill
- Experience with the operation of laboratory and pilot-scale manufacturing equipment Experience in technology transfer, scale-up, and late phase clinical development
- Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment, including process, equipment, and facility validation experience
- Strong knowledge of DOE concepts and practice descriptive statistics
- Bachelor’s or Master’s degree in chemistry, biology/microbiology, bacteriology, or associated scientific discipline required
- 15 year of industry experience, minimum of 10 years directly applicable job experience
4
Drug Product Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of drug product. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for drug product
- The successful candidate will be responsible for technical planning and execution of formulation development, drug product process development, primary packaging development, technology transfer to CMOs, scale-up, characterization and validation activities for protein therapeutics programs
- Lead and manage assigned DP Technical sub team
- Accountable for the network level technical decisions related to the product
- Must be fluent in data analysis
- Actively identify and implement manufacturing procedure improvements intended to optimize existing processes and ensure achievement of regulatory and safety requirements
- Report findings to management team and team members with recommendations for improvement
- Manage the daily activities of the Drug Product Team to ensure the accuracy, completeness, and appropriateness of product data included in the product database
- Monitor and evaluate state and federal regulations and legislation impacting data within the drug product database
- Recruit, select, manage, and develop members of the Drug Product Team and immediate reporting staff
- Coordinate product photo shoots with sales and customers
Qualifications for drug product
- Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership
- Mastery of scientific, technical, & leadership practices and theories with broad and/or in-depth progressive experience
- MS with 7 years, or PhD with 5 years in related scientific area
- Minimum 12 years’ experience in commercial /business and manufacturing (operations, quality, technology, planning), roles required with a significant portion in management/leadership positions
- Compliance – Has experience and ability to achieve compliance goals, through a risk based approach has a deep understanding of GMP and EHS compliance and compliance risk in modality (API, Drug Product, Sterile)
- World Class Supplier Mindset – Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time
5
Drug Product Job Description
Job Description Example
Our growing company is hiring for a drug product. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for drug product
- Initiates and/or supports moderately complex investigations and resolution of issues / potential problems related to Drug Product Manufacturing
- Becomes familiar with new equipment, systems and technologies to understand and translate issues in order to create accurate documentation
- Coordinates and supports interdisciplinary working teams with recommendations, advice and action plans for moderately complex investigations, change controls, gap analyses and risk assessments
- Manages specific components of moderately large scale deviations
- Tracks and trends documentation and data as specified
- Maintains a GLP/cGMP environment and follows SOPs
- Adjusts responsibilities and activities to meet client and internal expectations
- Follows up on open documents to ensure close out of investigations to enable product release in a timely manner
- Provides support to internal and client audits as needed
- Reliably executes and writes well defined SOP’s and manufacturing batch records
Qualifications for drug product
- Depth of Manufacturing Knowledge – Has proven skills and expertise at management level in modality (API, Drug Product, Sterile)
- Strategic Thinking – Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain
- Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, negotiation to work outside boundaries as a norm
- End to End Mindset – Ability to apply understanding of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute supply chain optimization
- 10-15 years industry experience in aseptic product manufacture (clinical product and/or commercial product) or protein drug products incl process validation
- Prior experience in the design and building and ramp-up of a Drug Product aseptic manufacturing facility