Drug Product Resume Sample
Wendell Davis
29424 O'Hara Mountains,
Detroit,
MI
+1 (555) 159 8273
Work Experience
Drug Product Project Leader
07/2015
-
PRESENT
San Francisco, CA
- Actively participate in teams, projects, networks / platforms. Fulfill all related tasks and responsibilities related to own discipline Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level to any other relevant project team member(s)
- Design, plan, perform and monitor all assigned activities. Ensure quality, quantity and timelines in all assigned projects, networks and / or platforms. Support and assign associates in specific projects/networks. Coach on target dates and priorities
- Proactively participate in budget forecast, grant preparation and tracking of invoices. Ensure costs and cost awareness in all assigned projects / networks
- Advise team members and work according to appropriate SOP’s, GLP, DQP, GMP, OQM, HSE, ISEC and Novartis guidelines Interpret results, evaluate data, draw relevant conclusions and write reports
- Contribute to optimization of scientific/technical activities in assigned projects, network / platforms / processes
- Contribute to risk analyses / peer review and process challenge meetings
- Proactively support generation of international registration documents Interact with authorities where appropriate Interact/collaborate with Research/other functions to facilitate transfer of knowledge and deliveries of DS / DP
Drug Product Engineer, Downstream Processing
05/2008
-
01/2015
Houston, TX
- Relevant industrial experience, thorough understanding of development activities and processes and broad scientific and strategic background
- Thorough understanding of development activities and processes of biologics drug product and broad scientific and strategic background
- Excellent scientific project management and leadership skills. Excellent presentation skills
- Excellent English required (oral & written); good skills in German as site (local) language desired (oral)
- Demonstrated successful experience with working in interdisciplinary teams, track record of creativity, problem solving and productivity in projects
- Proficient with Microsoft Windows, Word, Excel and the Alchemy Product User Interface (Product, Global Tables)
- Experience or familiarity with commercial drug database and their applications
- Excellent interpersonal, communication and organizational skills, and a customer-oriented focus
Summer Internship Formulation & Drug Product Sciences
07/2005
-
02/2008
San Francisco, CA
- Actively support TRD on audits and inspections / Due diligence teams Provide quality assessment of potential in-licensing products in a timely manner and support follow-up activities as appropriate
- Proactively contribute to setting, updating and monitoring of team goals Translate team goals into daily work
- Write impactful and wide-reaching process-related development guidelines and drive their implementation; write excellent scientific reports intended for external partners and support generation of registration documents; interact with authorities where appropriate; act as technical expert in audits, inspections or due diligences
- Interpret results, evaluate data, draw relevant conclusions; supervise project related scientific/technical activities; perform complex tasks without having established procedures. Review and approve analytical results generated by others; critically evaluate results and challenge conclusions made by other scientists
- Work according to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines; lead initiatives to ensure proactive compliance and continuous improvement
- Communicate, address and solve problems (e.g. deviations and unexpected results from experiments) within own and broader area of responsibility; communicate effectively across organizational interfaces; lead the transfer of know-how or procedures to other departments or external contractors, including troubleshooting and on-site training
- Work according to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines; lead initiatives to ensure proactive compliance and continuous improvement; advise team members and ensure all own and team activities are aligned with overall drug development process
- PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline with excellent theoretical and scientific knowledge. Proficient scientific/technical writing skills
Education
Everest University - Tampa Campus
2000 - 2005
Bachelor's Degree in Pharmacy
Professional Skills
- Demonstrate an effective and flexible communicate style, including excellent verbal, written communications, presentations skills ad influencing skills
- Strong presentation skills and scientific / technical writing skills
- Proven ability to work in a fast paced environment with demonstrated capacity of handling multiple task with appropriate prioritization
- Excellent English required (oral & written). Good skills in site (local) language desired (oral)
- Applies project management skills and concepts to lead or manage projects with an interdisciplinary project team, and from planning stage to project completion
- Training and experience in Design of Experiments and other statistical methodologies
- Majority of manufacturing experience in sterile/ aseptic processing or formulation and filling
How to write Drug Product Resume
Drug Product role is responsible for manufacturing, leadership, english, design, training, database, auditing, planning, reporting, education.
To write great resume for drug product job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Drug Product Resume
The section contact information is important in your drug product 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
- Telephone number
Work Experience in Your Drug Product Resume
The section work experience is an essential part of your drug product 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 product 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 product position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Drug Product resume experience can include:
- Demonstrated strong emotional intelligence leadership skills with ability to lead organization of 15+ staff
- Excellent communication and presentation skills
- Zero to two (0-2) years relevant experience in laboratory or manufacturing
- Demonstrated ability to follow detailed directions in a laboratory/manufacturing environment
- Experience Laborant/in EFZ – Galenik/ Biologie/ Mikrobiologie
- Proven record of technical capabilities
Education on a Drug Product Resume
Make sure to make education a priority on your drug product resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your drug product 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 Product Resume
When listing skills on your drug product 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 product skills:
- Proven ability to work in a fast paced environment with demonstrated capacity of handling multiple tasks with appropriate prioritization
- Industry experience dealing with proposal writing and/or sales lead generation
- Excellent knowledge on biopharmaceutics and bridging strategies
- Sterile dosage form development/cGMP manufacturing experience would be a distinct advantage
- Lean Manufacturing / Six Sigma Experience
- Experience with cGMP, manufacturing, machine operations, and data entry
List of Typical Experience For a Drug Product Resume
1
Experience For Drug Product Project Leader Resume
- Provide support to Sales and Marketing on file content and editorial policies
- Work autonomously as well as collaboratively with the Drug Product team and other Gold Standard or client cross-functional teams
- Work with internal teams to translate client needs and expectations into reality
- Assist the Vice President, Sales in identifying market potential by identifying client requirements, defining market, competitors’ share, and competitors’ advantages and weaknesses, forecasting projected business, establishing targeted Company share
- Performs various semi-routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations
2
Experience For Drug Product Specialist Resume
- Responsibilities include utilizing work estimates from internal technical parties for use in proposal generation; closely interacting with business development team members on overall proposal strategy and construction; and facilitating proposals and work orders through various stages of completion in the bid process for all Drug Product sites
- Define capabilities required at the CMO to successfully support new product introduction
- Assess gaps in capabilities and implement plan to build required capabilities at CMO to support technology transfer
- Author, review and approval of relevant technical documentation, protocols, reports, and regulatory submissions, including but not limited to Basis of Design, Process Risk Assessment, Technology Transfer Plan, Validation Master Plan, etc
- Ensure that all technology transfers are right first time, and are implemented in a timely manner while meeting the requirements for quality, cost and customer service
3
Experience For Director, Drug Product Manufacturing Resume
- 40%:Serve as in-house technical expert for assigned products, responsible for supporting all ongoing commercial programs and assuring a robust and resilient supply of products
- Prioritize and drive investigation processes to closure, using standardized approaches, such as KT and A3, to timely closure such that supply is not negatively impacted. Ensure that timeline for tasks are met and facilitate corrective action to get the timeline back on track when adverse events cause a task to slip
- Troubleshoots complex manufacturing process problems and issues
- Manage and maintain change control throughout appropriate product groups
- Development & maintenance of technical product knowledge database and technical documents for assigned products. Dissect and interpret data from various sources, using that information to create scientific reports that when compiled represents a documented summary of known product knowledge
- Actively engaged in professional industry forums with an eye towards staying current
4
Experience For Sales Operations Specialist, Drug Product Resume
- 20%:Continue to grow as a respected technical leader by
- Assist the Pharmaceutical Development group with technology selection, process design, development and optimization
- Ensure that all technology transfers and Process Validation are right first time, and are implemented in a timely manner while meeting the requirements for quality, cost and customer service
- Interacts and communicates with clients and auditors regarding operations
- Trains employees in production methods, cGMP guidelines, and SOP’s
- Drafts, reviews, revises, and executes batch records.
5
Experience For Manager, Drug Product Data Resume
- Champions Althea’s culture and empower employees to take responsibility for their jobs and goals
- Maintains employee work schedules
- Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication
- Manages for results by setting and communicating goals and metrics
- With minimal supervision, execute process development strategies to define manufacturing processes for commercialization
- Maintain all Gold Standard Drug Database product hierarchy tables and associated data
6
Experience For Summer Internship Formulation & Drug Product Sciences Resume
- Work with Manager, Product Data Communication to coordinate workflow
- Oversee the review and approval of drug products entered or updated in the drug product database by other Pharmacists or Editorial Associates
- Assist with quality assurance of drug product data
- Work with Elsevier Drug Database development team to implement/test clinical algorithms in future tools/clinical decision support modules
- Reliably executes well defined SOP’s
- Oversees and schedules production operations and employees within cGMP guidelines
- Interacts with potential clients, client auditors and regulatory bodies as a visual inspection and cGMP subject matter expert
7
Experience For Manager, Drug Product Inspection Resume
- Oversees reviews and approves inspection protocols, SOPs, forms, and study reports
- Directs and provides expert knowledge in the day-to-day function of Drug Product Inspection
- Identifies, recruits, and retains top-notch talent
- Champions Althea’s culture and empowers employees to take responsibility for their jobs and goals
- Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities
- Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management
- Provides oversight and direction to the employees in accordance with Althea’s policies and procedures
List of Typical Skills For a Drug Product Resume
1
Skills For Drug Product Project Leader Resume
- Strong knowledge of relevant GLP, GMP regulations and policies
- Lifting and moving supplies and equipment (up to 50 pounds)
- Assume all aspects of testing including sample cataloging, submission, analysis and collection of results
- Typical office and laboratory bending, stooping, lifting requirements apply
- Broad and deep understanding of the pharmaceutical and biotech markets and decision-making dynamics within the companies operating in this space
2
Skills For Drug Product Specialist Resume
- Able to use scientific judgment in solving problems and decision-making
- Coordinate collaborations and contracts with contract testing organizations (CTOs)
- Understanding of formulations for nucleic acids
- BS, MS or PhD in Pharmaceutical Chemistry, Chemistry, Chemical Engineering or related disciplines
- MS or Ph.D. in Pharmaceutical Chemistry, Chemistry, Chemical Engineering or related disciplines
- Broad and profound understanding of development activities and processes in pharmaceutical sciences. (early phase and late phase development)
- Thorough understanding of development processes
- Design and implement processes (and potentially novel equipment) to enable scale up of mRNA drug product manufacturing
- Evaluate and establish process design space using Quality-by-Design principles
3
Skills For Director, Drug Product Manufacturing Resume
- Enable process transfer to internal or external manufacturing organizations and suppliers
- Knowledge of regulatory requirements with regard to raw materials used in vaccine manufacturing
- Location is in Indianapolis, IN at Lilly Technology Center – North
- Estimated US and OUS travel, 0-20%
- Customer focused, results oriented, science driven and embrace Shire’s values
- Ph.D. in Science (e.g. Pharmacy, Biochemistry, Chemistry) with focus on pharmaceutical technology OR equivalent education
- Experience (3-5 years) in biopharmaceutical sciences, including expert knowledge in developing liquid and lyophilized protein formulations, process development and tech transfer. Experience with sustained release systems for proteins would be an optional asset
4
Skills For Sales Operations Specialist, Drug Product Resume
- Experience in protein analytics and GMP systems of advantage
- Coordinate efforts between different internal and external teams such as Process Development, Bio-analytical, Formulation and Preclinical
- Experience (min 5-8 years) in biopharmaceutical sciences, including expert knowledge in developing liquid and lyophilized protein formulations, process development and tech transfer. Experience with sustained release systems for proteins would be an optional asset
- Excellent scientific leadership skills
- BS, MS or Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, Biology, Chemical Engineering or related discipline with 5-7 years(BS), 3-5 years (MS) or 0 -3 (Ph.D.) of laboratory research experience
5
Skills For Manager, Drug Product Data Resume
- Expertise in formulation development of vaccine drug product formulations
- Able to work independently and take scientific direction from senior scientists
- Contributes to, leads and/or supervises the integration of formulation, process development, modeling, real-time measurement, and /or laboratory measurement integration to enable a rapid development workflow and an automated control strategy of drug product. Typical responsibilities include
- Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities e.g., containment / sterile labs
- Strong knowledge of relevant SOP, GLP, DQP, GMP regulations and policies
- Experience associated with filings and change control
6
Skills For Summer Internship Formulation & Drug Product Sciences Resume
- Thorough knowledge of state-of-the-art instrumentation / equipment
- Significant experience in the pharmaceutical industry, combining sales and marketing experience with a track record in the successful closure of significant deals, building strategic relationships and a demonstrable network of senior level contacts within the drug product development and manufacturing outsourcing buyer market
- Design and execute experiments to interrogate process performance
- Work in teams and individually with little direct supervision
- Communicate with cross-functional counterparts and/or CMO’s
- Identify, evaluate, qualify and manage CMO’s for GMP production of drug products
7
Skills For Manager, Drug Product Inspection Resume
- Write RFPs, negotiate proposals, manage a budget and verify invoices are consistent with work performed by CMO’s
- Provide CMC and technical leadership for company’s global regulatory submissions (INDs, IMPDs, NDAs, MAAs, Meeting Requests, Briefing Documents, Responses to Health Authority questions, etc)
- Experience in a scientific/technical CMC role with a history of working with and managing global CMO’s in a virtual manufacturing environment for the production of clinical and commercial drug product
- Provide technical leadership and support for technical transfer activities, and deviations, investigations, CAPA and change control for global commercial biologic Drug Product manufacturing
- Experience with the technical transfer of aseptic pharmaceutical drug products within the organization and to CMOs, with a proven record of achievement in technical and project leadership
- Create policies, directives and procedures to ensure maintenance of technical best practice and regulatory compliance across the Alkermes’ drug product production network to ensure reliability of supply
- Professional or chartered status with a relevant professional body
- Subject Matter Expert level of process, equipment and control across the pharmaceutical drug product lifecycle for a range of in process and finished product technologies, including design and control of these processes
- Knowledge of global regulatory requirements and industry best practice concerning cGMP manufacturing, validation, quality systems, equipment innovations, upgrades and instrumentation to ensure manufacturing best practice
8
Skills For Director, Drug Product Business Development Resume
- Experience of risk management and risk assessment; demonstrate an understanding of how to effectively lead a risk assessment activity, appropriate tool selection and the risk management lifecycle
- Experience with the technical transfer of pharmaceutical drug products within the organization and to CMOs, with a proven record of achievement in technical and project leadership
- Close-out investigations and deviations at CMOs
- Actively identify and implement manufacturing procedure improvements intended to optimize existing processes and ensure achievement of regulatory and safety requirements. Update GMP documentation as required
- Ensure work environment meets Boehringer Ingelheim and industry standards. Initiate lean manufacturing techniques in order to actively reduce process and change over cycle times
- Additional competencies include, but are not limited to: stakeholder management, influencing/motivating teams without direct authority, presenting data, performing FMEA & gap assessments, and Lean manufacturing concepts
- Demonstrated proficiency in MS Office programs and associated computer programs
9
Skills For Drug Product Engineer, Downstream Processing Resume
- Read, develop and understand procedures and other controlled documents
- Ensures compliance with all manufacturing processes in accordance with Government (cGMP, FDA, DEA, OSHA, and Safety) and Company Policies, Procedures, Goals and Objectives
- Follow all relevant department policies, procedures, SOP and other requirements during project execution and act at all times within the BI standards/ethics policies
- Lean manufacturing certification and experience desired
- Working closely with the Vice President, Sales to establish the commercial strategy, making goals, actions and budgets for the Region
- Coaches, mentors and develops staff, including overseeing new employee onboarding and providing career development planning and training opportunities
10
Skills For Drug Product Lead-cell & Gene Therapies Resume
- Responsible for producing group metrics, analyzing results and presenting conclusions to senior manufacturing management
- Call on prospective accounts, provide technical and administrative product information, coordinate presentations, and support proposal generation. Prepare client-specific presentations and other data to respond to client needs
- Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance development planning
- With minimal supervision, design and execute complex experiments to characterize drug product manufacturing processes utilizing various technologies
- Plan, develop, implement and evaluate advertising, and trade promotion programs
- Reliably executes and writes well defined SOP’s and manufacturing batch records. Initiates and writes revisions to current GMP/SOP guidelines
- Pass visual acuity exam according to SOP guidelines
- Engages employees by creating a climate in which they want to do their best
- Recruitment, selection, management, and development of Drug Product Team and direct reporting staff
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