Drug Product Development Job Description
Drug product development
provides quality system consultation, training, and assessment to ensure product teams are aligned with current quality system regulatory requirements and current industry trends.
Drug Product Development Duties & Responsibilities
To write an effective drug product development job description, begin by listing detailed duties, responsibilities and expectations. We have included drug product development job description templates that you can modify and use.
Sample responsibilities for this position include:
Co-ordinating with the customer for new projects, preparing technical proposals addressing their needs and drawing up cost estimates for project work
Plan, co-ordinate, and oversee the work activities of scientific staff within the different groups
Supporting drug product process development work at internal and external manufacturing sites
Planning and executing lab-scale and at-scale process development and characterization studies
Serving as subject matter expert on technology transfer and cross functional teams
Executing risk assessments and preparing process control strategies
Presenting scientific data to technical teams
OEnsure fundamental engineering principles are applied to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches
Establish internal capabilities for biologic formulation and drug product development and hire a best-in-class team to design and execute phase-appropriate development activities for biologics products in mid to late stage development and up to commercial registration
Responsible for all scientific, strategic, and project planning and execution aspects of biologic formulation development, drug product process development, primary packaging development, technology transfer, scale-up, and validation activities, based on organizational goals and project timelines
Drug Product Development Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Drug Product Development
List any licenses or certifications required by the position: PMP, PHD
Education for Drug Product Development
Typically a job would require a certain level of education.
Employers hiring for the drug product development 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, Chemical Engineering, Biotechnology, Biochemistry, Science, Pharmaceutical Sciences, Biology, Biomedical Engineering, Pharmaceutical Science
Skills for Drug Product Development
Desired skills for drug product development include:
EU
Nucleic acid chemistry and biology
GLP and GMP requirements are
Protein science
Current US
Global Regulations
ICH guidance and relevant standards and quality system requirements for biological product manufacturing
Harvest/purification process
Statistical design of experiments and analysis
Analytical methodologies
Desired experience for drug product development includes:
The ability to work with a high degree of independence, self-starters
Ability to work together in a constructive way with peers, subordinates and seniors in anticipating and resolving issues
Experience (3-5 years) in biopharmaceutical sciences, including expert knowledge in developing liquid and lyophilized protein formulations, process development and tech transfer
Excellent English required (oral & written)
Understanding of drug product manufacturing process operations such as mixing, sterile filtration, and aseptic fill/finish
Use of membrane technologies for preparing protein formulations and experience with aseptic technique
Drug Product Development Examples
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Drug Product Development Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of drug product development. 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 development
- Will oversee interactions with contract manufacturing organizations to deliver drug product supplies for clinical development up to commercial registration
- Responsible for oversight and integrity of all Planning, Budgeting & Resourcing System (PBR) processes
- Provide direction and counsel to the Scientific Directors to meet business objectives
- Calculate gaited costs for inclusion in Financial LBE
- The incumbent is expected to operate independently to accomplish the goals and responsibilities of the position
- DP leadership position for pipeline molecules including process development and characterization
- Project leader in commercial drug product technology transfer activities such as, process evaluation, validation documentation writing and review, root cause analysis and risk assessments
- Representing DPDO in cross functional matrix teams as it relates to biosimilar and novel biologic products within Teva
- Interface between DPDO and Sterile Device Technologies (SDT) group
- Involvement in capital projects such as Biological Manufacturing Facility (BMF) at West Chester
Qualifications for drug product development
- Experience executing formulation, stability, and product characterization studies
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment
- Demonstrated track record of successful formulation and drug product development, supporting clinical/commercial programs for recombinant protein products, including filing of INDs/IMPDs and BLAs
- Deep technical understanding of all aspects pertaining formulation and drug product development of liquid and lyophilized biological products, including experience with multiple primary packaging configurations and combination products
- The ideal candidate will also have proven experience with contract manufacturing organizations including establishing and managing clinical supply agreements
- Effective communication, collaboration, and negotiation skills
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Drug Product Development Job Description
Job Description Example
Our growing company is looking for a drug product development. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for drug product development
- Records activities and progress of key account efforts
- Ensure that Drug Product is formulated and supplied to meet the agreed needs of the Project Team
- Provide the GEDS interface with the wider Project Team
- Coordinate the activities of the external team and raise issues as necessary with project teams
- Engage and assess supplier proposals against project requirements and make sourcing recommendations with Procurement/NCGOM
- Ensure safety, quality and ethical standards are appropriately maintained in CRO/CMO operations
- Ensure generation and storage of appropriate documentation (including contribute to regulatory submissions in support of clinical studies where required)
- Have a project plan and an assessment of risks that are reviewed and endorsed by the relevant lines
- Make appropriate and accurate budget provision to deliver the agreed project plan
- Use current R&D project governance processes for communication and review of project progress and issues
Qualifications for drug product development
- Be energetic, enthusiastic and hungry for success
- Sound knowledge of formulation development and stabilization of protein therapeutics
- Experience performing analytical characterization of study samples using various protein biochemical or biophysical methods
- A PhD or M.S
- Advanced degree (desirable PhD) in pharmaceutical technology, biotechnology or other relevant discipline
- Broad experience (at least 3 years) in pharmaceutical development or production
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Drug Product Development Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of drug product development. 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 development
- Comply with applicable quality and regulatory requirements in all aspects of work
- Interpret and understand drug product stability and safety requirements product/material interactions, to successfully evaluate and recommend materials, design, and configuration of primary packaging to meet drug product protection needs
- Execution of formulation and process development study protocols, stability and product characterization studies
- Authoring study protocols and reports
- Executes formulation and process development studies for liquid and lyophilized parenteral drug products of biologics
- Execute analytical methods and technologies to support formulation and process development
- Manufacture non-GMP drug product samples for supportive stability studies and preclinical use
- Method development and writing of technical and standard operating protocols
- Expands technical knowledge and builds understanding of characterization techniques
- Cross-train with other scientist on techniques and data analyses approaches
Qualifications for drug product development
- Thorough understanding of respective methods in analytical development of recombinant proteins
- Active knowledge of English language required (oral & written)
- BS degree in Pharmacy, Pharmaceutical Sciences or a related field with at least 13 years of experience OR a MS, Pharm
- Must have a current and active Pharmacist License is required
- Knowledge and experience of Pharmaceutical and/or clinical drug development is required
- Knowledge and understanding of scientific process that are used to deliver compounds to a patient is required
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Drug Product Development Job Description
Job Description Example
Our company is growing rapidly and is hiring for a drug product development. 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 development
- Review literature to understand what is new in the industry
- Assist scientists in the group in other drug product development activities
- Understand different formulation techniques including tableting, coating, granulation and operate the corresponding equipment
- Keep a neat and tidy lab environment and will always be mindful of working safely
- Determination and characterization of process parameters associated with liquid and lyophilized fill-finish operations - these will include freeze-thaw and heat transfer, mixing, filtration, pumping, filling and lyophilization
- Application of suitable scale-down models representative of the large-scale process will be a key activity in this role
- Rational formulation design/selection plus a variety of characterization studies relevant to the stage of development
- Interpret relevant analytical data to drive formulation selection and characterization decisions
- Manage and direct the activities of the HT testing team to ensure that high quality data are generated in a timely manner
- Outline the requirements of method establishment, data analysis and reporting, and lab operations to be consistent with GLP/toxicology studies and to support regulatory/shelf life enabling studies
Qualifications for drug product development
- Have excellent written and verbal communication skills, particularly in areas of negotiation, persuasion, research & problem solving
- Be highly motivated with demonstrative interpersonal, presentation and organisational skills
- Familiar with the clinical trial design is preferred
- Experience working on supporting clinical trials in a hospital setting for oncology and/or other therapeutic areas is preferred
- Experience of the biologics drug dosing design and administration in various clinical development stages is preferred
- Up to 20% domestic and international travelR&D
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Drug Product Development Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of drug product development. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for drug product development
- Qualify methodologies as appropriate per ICH Q2 (R1) requirements for routine use, drive the rationale for the level of qualification required
- Oversee and manage the transition of methods and data analysis to a high throughput/automation platform
- Liaise with analytical development team to ensure performance data are shared, and methods can be optimized
- Report, track and trend analytical data, and serve as the subject matter expert on project teams
- Generate high quality documentation to support regulatory filings
- Work with the Drug Product Development teams (OSD & Parenterals), the Strategic Business Support team and the appropriate Value Stream leadership team to conduct a ‘gap analysis’ annually of the scientific capabilities versus the requirements to support the portfolio
- Coordinate and lead tech transfer meetings, attend process development sub-team meetings as necessary, and manage information flow and decisions
- Responsible for (as appropriate) leading, facilitating, or coordinating all activities pertaining to tech transfer, which includes initial process/facility fit, process transfer, manufacturing readiness, production and testing, and tech transfer/project closeout
- Manage the tech transfer project schedule with external manufacturing partners and integrate this with other scheduling functions, so the schedule is visible and usable by relevant stakeholders
- Cultivate relationships with external business partners and internal stakeholder groups
Qualifications for drug product development
- Experience in GMPs, formulation development and writing of regulatory submissions
- Identify the mechanisms governing drug product process and product performance and scale up using underlying physical and chemical principles properties of materials
- Evaluate critical to scale parameters and equipment parameters that can affect performance at a larger scale (e.g, blend times, shear rates, compaction/compression forces)
- Process and scale-up modelling of pharmaceutical processes to prepare oral, parenteral, solid and liquid dosage forms
- Experience in managing drug product process and device development from Phase 1 to post-approval
- Demonstrates technical proficiency, creativity, collaboration with others, and independent thought