Scientist, Formulation Job Description
Scientist, formulation
provides advanced technical support for lyophilization and lyophilized products for aseptic drug products manufactured for internal or external products.
Scientist, Formulation Duties & Responsibilities
To write an effective scientist, formulation job description, begin by listing detailed duties, responsibilities and expectations. We have included scientist, formulation job description templates that you can modify and use.
Sample responsibilities for this position include:
The selected candidate will work closely with protein engineering scientists, peptide chemists, ADME scientists, and biologists to characterize and understand how biophysical and formulation properties of novel biotherapeutic peptides, proteins, and antibodies relate to the overall profile of a clinical candidate molecule
Develop new technologies, processes and product formulations for solid dosage form of pharmaceuticals
Design and conduct pre-formulation, formulation development, process development, process optimization, scale up and manufacturing and solve complex problems
Represent Formulation Development and act as subject matter expert with government agencies
Write, generate and review protocols, development reports, and master batch records
Help and develop the process of the plant and assist in evaluating new equipment
Be responsible for creating, testing, evaluation, re-evaluation and formatting the product development image to conceptualization
Validate processes, procedures and formulations consistent with GMP requirements
Source, develop and work with outside laboratories and manufacturing facilities to identify and support innovative products and delivery methods
Formulate and modify existing formulas to meet regulatory guidelines, cost parameters and claims
Scientist, Formulation Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Scientist, Formulation
List any licenses or certifications required by the position: GMP, EH&S, SOP
Education for Scientist, Formulation
Typically a job would require a certain level of education.
Employers hiring for the scientist, formulation job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Science, Chemical Engineering, Biochemistry, Engineering, Biology, Pharmaceutical Sciences, Pharmacy, Education, Manufacturing
Skills for Scientist, Formulation
Desired skills for scientist, formulation include:
Drug development processes for progression of a biological candidate
Lyophilization and lyophilization cycle development
GLP/GMP requirements
Degradation pathways
Protein
Considerations for protein structure and stability considerations
HPLC
Nucleic acid chemistry
Principles and theories
Analytical and bio-analytical methods for gene therapies
Desired experience for scientist, formulation includes:
Think creatively in prototype preparation and in problem solving
Collaborate with other corporate departments to define project scope, timing, product cost
Maintain working knowledge of industry trends, ie
Will work closely with other members of the R&D team, Operations, Marketing, Regulatory, Quality, Laboratory
Evaluate projects, initiate literature search, plan experiments to develop formulation and conduct pre-formulation experiments leading to sound formulation and process
Design strategies to resolve problems and evaluate patents
Scientist, Formulation Examples
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Scientist, Formulation Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of scientist, formulation. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for scientist, formulation
- Keep up to date on new/updated drug delivery and technological advancements in the pharmaceutical industry
- Support new equipment introduction and all associated technical, design and qualification documentation where required
- Support on all issues pertaining to the quality and technical aspects of Stage 1 product development, Stage 2 process performance qualification and Continuous process verification
- Support the preparation of R&D related documentation (specifically CMC modules 2 and 3 of IND, NDA) to support global registration filing
- Responsible for maintaining, tracking and ordering supplies to ensure reagents are available to complete projects with a rapid turnaround
- To evaluate product and process using appropriate techniques physical stability
- To prepare and ensure all documentation (BMR’s, SOP’s
- Evaluate product and process using appropriate techniques physical stability
- This position will perform formulation development activities to support early stage drug product development
- Performs general lab housekeeping, cleaning/sterilizing lab and lab materials, disposal of trash and recyclables, ordering and stocking supplies
Qualifications for scientist, formulation
- Strong knowledge of formulation and manufacturing sciences (product development, process research, scale-up and technology transfer) in Inhalation (single dose blister DPIs and MDIs, dose counters and human factor assessments) acquired through academic training plus on-the-job experience
- Experience in MDI and DPI blister formulation, manufacturing and testing is
- 3rd level qualification in a science related discipline (Chemistry, Engineering Materials Science, Pharmaceutical Science,) and 3+ year's experience in R&D environment.?
- Experience in cell culture media optimization and formulation is required
- Technical knowledge and experience in formulation science including formulation design, optimization, and scale-up
- Must be a self-motivated individual that can function both independently, part of a team
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Scientist, Formulation Job Description
Job Description Example
Our growing company is looking to fill the role of scientist, formulation. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for scientist, formulation
- Evaluate complex technical issues to introduce new concepts, products, equipment or processes to develop new applications
- Design and execute pre-formulation and formulation research for the discovery of oral and parenteral injectable drugs
- Responsible for designing and conducting solubility and stability assessments to support in vivo studies in early phases of project
- Profiling physio-chemical properties of compounds
- Prepare dosing solutions and measure concentration for in vivo DMPK/pharmacology studies
- Summarize, interpret data and present findings to fellow team members
- Maintain detailed laboratory notebook of results
- Attend group and project meetings as required
- Other drug metabolism/bioanalytical duties as necessary
- Align with manager for the product performance valorization, support the sample preparation, request, in time
Qualifications for scientist, formulation
- 5-8 years inhalation product development experience with associated inhaled product analytical testing
- A BS/MS degree in Pharmaceutics/Pharmacy/Chemistry or other closely related field
- M.Sc, equivalent or higher degree in Physical Chemistry, Material Science or similar disciplines
- Candidate with experience in surfactants, emulsion, colloid science or polymers is advantageous
- Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in techniques and can understand their application in context of pharmaceutical services offerings
- Understand the details of regulatory CMC filing package and analytical and formulation documentation required
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Scientist, Formulation Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of scientist, formulation. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for scientist, formulation
- Understanding developability profile consists of evaluating a molecule’s physical or chemical stability using a variety of analytical techniques
- Keeps current with developments in area of formulation science and identify and implement applications which will benefit DAS
- Delivers presentations or reports that distill complex ideas into clear results and proposals
- Communicates and appropriately documents work in the form of internal reports / presentations and external publications / presentations (when appropriate)
- Serves as SME or project leader on large multi-disciplinary project teams to collaborate, provide technical input and deliver results aligned with team deliverables
- Develops strategies for using external contact network
- Serves as EH&S advocate for work group, ensuring understanding and adherence to policies and procedures
- Responsible for the development of innovative personal care products containing patented company technologies for sale and distribution throughout the world
- Responsible for the overall design and development of creams, lotions, serums, sprays, and nutritional products
- Responsible for troubleshooting and problem solving in various situations regarding the use of scientific methods and logic
Qualifications for scientist, formulation
- Quality by Design concepts and principles
- Transdermal and topical dosage forms design and development
- Communicating clearly and concisely, both orally and in writing, both internally and with external partners
- Education in relevant major
- Ability to clearly document and articulate technical information and summarize and present major program/project development results to management and cross-functional team members
- General understanding of statistics as applied to design of experiments (DOE) and analysis of data
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Scientist, Formulation Job Description
Job Description Example
Our company is looking to fill the role of scientist, formulation. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for scientist, formulation
- Providing test article, information, advice and support to TESMs and CROs for formulation issues arising on CRO studies
- Act as Analyst for Validation of Analytical Methods and subsequent Analysis of Test Samples
- Provides support to (or may lead) product/process development and commercialization activities for new immediate release and modified release solid oral dosage, liquid oral dosage forms and semisolid topical dosage forms to facilitate “First-to-File” and “First-to-Market” corporate goals
- Perform effective problem solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product/process development and improvement projects
- Generate accurate, reliable data by following established procedures and practices
- Hands-on formulation design, development and optimization with guidance as appropriate
- May lead and/or Collaborates with multidisciplinary teams to resolve complex product development issues and respond to internal and external audits
- Maintain scientific currency
- Collaborate with Formulation & Process Design team regarding the design and execution of pilot and commercial manufacturing operations
- Review batch records, incident investigation reports, change controls, market complaints, annual product review, product development protocols and reports, drug master files, validation documents, equipment qualification reports, technology transfer dossiers, stability data, raw material data trend, CAPAs, in-process and finished product analytical data for understanding the process knowledge and identify the risks to the quality of the product
Qualifications for scientist, formulation
- Experience in MDI and DPI blister formulation, manufacturing and testing
- Experience in common practices and procedures such as aseptic sample handling, stability program and stability pull, analytical method development and testing are required
- Good understanding of FDA and ICH guidelines associated with drug product development and drug substance and drug product stability assessment are required
- Familiar with selection of container/closure systems including prefilled syringes is required
- Must have excellent scientific writing, communication, presentation, documentation, and organization skills
- Demonstrated abilities in the areas of formulation development, injectable (and lyophilization) background and manufacturing are required
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Scientist, Formulation Job Description
Job Description Example
Our company is growing rapidly and is looking for a scientist, formulation. 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 scientist, formulation
- Preparing technical presentation for review
- To update information bank on novel drug delivery, review of new technology product/excipients in the market
- To evaluate and complete projects in targeted timeline
- Risk taking and decision making will be critical components of the role in helping determine project success relative to technical problems and / or the resolution of critical issues
- Work on highly interdisciplinary project teams with defined targets and milestones
- Work highly interdisciplinary project teams with defined targets and milestones
- Preparation of GMP batches – larger versions of prototype scale
- Preparation of GMP/technical documents
- Documentation of all lab activities in electronic laboratory notebook
- Collaborate effectively within and across functional areas and possess advanced knowledge or experience in a specialized scientific area
Qualifications for scientist, formulation
- MS in Chemistry with a minimum of 6 years of experience or a Ph.D with a minimum of 3 years of experience in Pharmaceutics/Pharmacy/Chemistry or another closely related field
- Working knowledge and experience in formulation and manufacturing sciences (product development, process research, scale-up and technology transfer) in Inhalation (single dose blister DPIs and MDIs, dose counters and human factor assessments) acquired through academic training plus on-the-job experience
- Self-motivated - can function both independently part of a team
- HNC/HND or a Bachelor's degree in Biology, Chemistry, Biochemistry, or other related discipline, or the equivalent knowledge and experience
- BS/MS degree in Chemistry or Pharmaceutics with a minimum of ten years of industry experience performing pre-formulation and formulation or PhD degree in Chemistry or Pharmaceutics with two years of industry experience performing pre-formulation and formulation
- PhD degree in Pharmacy, Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline required