Drug Substance Resume Sample

4.6
19 votes

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Francisca Cruickshank
58621 Grady Point,  Philadelphia, PA
+1 (555) 653 5811

Work Experience


Drug Substance Working Group Lead-biotech
10/2016 - PRESENT
San Francisco, CA
  • Provide department-wide operations support for system/process improvement, evaluation of new technologies and CROs/CMOs, budget management, and resource prioritization
  • Interacts with clients and interdepartmentally to assure successful technical transfer and integration of processes into Althea’s manufacturing department and to complete manufacturing programs on schedule with well-planned support from all required departments
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
  • Demonstrated leadership of others in a manufacturing GMP environment
  • Performs various manufacturing tasks under the guidelines of established SOP’s and cGMP regulations
  • Embodies Althea’s cultural values and aligns daily actions with department goals and company culture
  • Zero to two (0-2) years of relevant experience in a manufacturing or laboratory environment
  • Work within strictly prescribed guidelines and as a reliable team member
  • Detail-oriented with very strong written and verbal communication skills
Supervisor, Drug Substance Manufacturing
04/2011 - 07/2016
Phoenix, AZ
  • Be the single point of contact for all Drug Substance process for all partners and therapeutic areas in the Moderna ecosystem
  • Applies detailed fundamental knowledge of own specialty area or scientific discipline into solving process development problems
  • Rapidly acquires theoretical and operational knowledge of laboratory equipment in own discipline. Trains and supervises other team members as necessary
  • Provides guidance and mentorship to less experienced colleagues and acts as a technical advisor
  • The Drug Substance-Expert leads collaborations with our process chemistry partners (within Merck and CDMOs) for Merck biopharma small molecule projects (NCEs)
  • The Drug Substance-Expert represents the process chemistry expertise within cross-functional teams and ensures high quality decision making on process development and supply of API
  • Contribution to strategic decisions in the department like out-sourcing models, guideline interpretation etc
Drug Substance Manufacturing Intern
12/2004 - 03/2011
New York, NY
  • Work within prescribed guidelines and as a team member
  • Capable with Microsoft Office applications (Word, PowerPoint) is essential
  • We are an EOE dedicated to a diverse work force and Drug Free work environment
  • Qualified M/F/D/V candidates are encouraged to apply
  • Completes all job related, ’read and understood’ and qualified GMP training tasks within Master Control (Quality System Software)
  • Builds sound relationships within the Downstream group, clients, and internal Althea departments to assure successful technical transfer and integration of processes into Althea’s Drug Substance Manufacturing department to complete manufacturing programs on schedule with well-planned support from all required departments
  • Embodies Althea’s cultural values by aligning daily actions with department goals and company culture
  • Performs various routine downstream GMP manufacturing tasks under the guidelines of Althea’s established policies and procedures with high focus on attention to detail
  • Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements

Education


Arizona State University
1998 - 2003
Science's Degree in Pharmaceutics

Professional Skills


  • Excellent English required (oral & written). Good skills in site (local) language (oral) are an advantage
  • Extensive experience in pharmaceutical development and manufacturing
  • Experience with the development and/or manufacturing of DS, relating to cell culture, fermentation, recovery and purification processes for biologics and associated analytics
  • Knowledge and experience relating to the application of Quality by Design principles and statistical analysis tools for evaluation of Drug Substance manufacturing processes
  • Broad interdisciplinary experience with interfacing functions to Chemical&Pharmaceutical-Development
  • Experience with technical and operational aspects of small- and large-scale fermentation and harvest equipment is required
  • Experience in systems biology is of advantage

How to write Drug Substance Resume

Drug Substance role is responsible for design, travel, training, integration, manufacturing, english, education, analysis, gmp, chemistry.
To write great resume for drug substance job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Drug Substance Resume

The section contact information is important in your drug substance resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Drug Substance Resume

The section work experience is an essential part of your drug substance resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous drug substance responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular drug substance position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Drug Substance resume experience can include:

  • Contribution to strategic decisions in the department like out-sourcing models, QbD-strategy etc.,
  • Contribution to in-license evaluations (due diligences)
  • The DS-Expert reports to the head of Drug Substance Development within Chemical & Pharmaceutical Development and works in a matrix environment with other functional experts (QC, Formulation)
  • The Drug Substance-Expert leads collaborations with internal and external process chemistry partners (PM-OT, Life Sciences and CMO) for Merck biopharma small molecule projects
  • The DS-Expert reports to the head of Drug Substance Development within Chemical & Pharmaceutical Development and works in a matrix environment with the CMC-Leader of the respective projects
  • Broad interdisciplinary experience with interfacing functions to CMC-Development

Education on a Drug Substance Resume

Make sure to make education a priority on your drug substance resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your drug substance experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Drug Substance Resume

When listing skills on your drug substance resume, remember always to be honest about your level of ability. Include the Skills section after experience. Present the most important skills in your resume, there's a list of typical drug substance skills:

  • Solid process chemistry experience (scale-up, pilot plant batches)
  • Experience in pharmaceutical development & chemical process development for at least 3 to 6 years
  • Experience with high potent drugs (containment) and conjugation of antibody drug conjugates (ADCs) is of advantage
  • Ph.D. in Science (e.g. Biochemistry or Bioengineering) with focus on mammalian expression OR equivalent education
  • Extensive experience (3-5 years) in biopharmaceutical sciences, including expert knowledge in upstream process development, process development and tech transfer
  • Lead DS sub teams consisting of subject matter experts for a project, ensuring timely completion of the project deliverables in the DS functional area (including DS process development and supply of pre-clinical and clinical drug product batches)

List of Typical Skills For a Drug Substance Resume

1

Skills For Supervisor, Drug Substance Manufacturing Resume

  • Project related experience in pharmaceutical development & chemical process development for at least 3 to 6 years
  • Represent DS in the CMC project team
  • Signal resource and/or technical issues and ensure alignment within DS and with the rest of the organization
  • Contribute to the design of drug substance development strategies with the functional groups in DS
  • Review and edit as responsible person the DS-related sections in regulatory submissions
  • Able to travel 20% across Europe
  • Manage stakeholder interactions
  • Profound cGMP knowledge
  • Profound GMP knowledge

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