Associate Director Of Drug Product Cmc
By EPM Scientific At Greater Boston, United States
• Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management
• Extensive experience from Discovery, Pre-formulation, Formulation to Commercialization
• Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
• Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) – highly coveted
• Experience authoring CMC sections for IND, BLA & MAA is highly sought after
Associate Director/Director - Formulations(Drug Product)
Svp, Head Of Drug Development
By Flagship Pioneering At Cambridge, MA, United States
Extensive experience in CRO management of drug discovery programs
Demonstrated leadership and success in management of translational activities with a proven track record of effective cross-functional collaboration
Develop and manage external relationships with academic and commercial partners.
Very strong communication and partnering skills.
Set drug discovery team goals and budgets
Prioritize resourcing within drug discovery portfolio
Director Of Drug Product Development
By Serán BioScience At Bend, OR, United States
Excellent time management skills with a proven ability to meet deadlines
Works directly with Executive Management on Company strategy, budgeting and forecasting
Makes final recommendations for capital expenditure to Executive Management
Extensive experience developing solid oral dosage forms for clinical and commercial products
Experience with aseptic dosage forms and fill finish operations is desirable, but not required
Excellent verbal and written communication skills
Associate Scientist Ii, Biologics Drug Product Development
By ABBVIE At , Irvine
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
CMC development experience in protein formulation, drug delivery, or analytical functions is preferred
Prior experience with drug product manufacture processes and lyophilization is a plus
Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms
Manufacture drug product formulation batches for evaluating formulation stability and/or to support animal studies
Conduct clinical in-use studies to guide dose solution administration
Senior Manager, Drug Development Strategic Operations
By Bristol Myers Squibb At , Princeton

Uniquely Interesting Work, Life-changing Careers

Research Associate, Drug Product Development
By Moderna At , Norwood, Ma
Vacation, sick time and holidays
Volunteer time to participate within your community
Paid sabbatical after 5 years; every 3 years thereafter
Here’s What You’ll Bring to the Table:
Generous paid time off, including:
Scientist, Drug Product Development
By Moderna At Norwood, MA, United States
Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projects
Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.
Experience working in matrix project teams with members from peer groups, CMC teams, R&D, CMOs and CROs.
Knowledge of GMP and GLP compliance
Family care benefits, including subsidized back-up care options and on-demand tutoring
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Fellow, Drug Product Development
By Moderna At Norwood, MA, United States
Prior management and mentorship experience; passion for people management and development
Minimum of 10 years (PhD), 14 years (MS), 16 years (BS) industry experience in biopharmaceutical development
Experience in managing development teams and serving on or leading such teams comprising membership from various functional areas
Experience in parenteral Drug Product development and commercialization, including working closely with external CDMOs.
Family care benefits, including subsidized back-up care options and on-demand tutoring
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Research Associate, Drug Product Development
By Moderna At Norwood, MA, United States
Relevant Experience: 0 – 2 years post Master’s Degree or 0 – 4 years post Bachelor’s Degree.
Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment
Knowledge of statistical design of experiments (DoE) and analysis
Knowledge of nucleic acid chemistry and biology is a plus
Preferred: Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
Preferred: Experience with nanoparticle formulation technology
Engineer I, Drug Product Development
By Moderna At Norwood, MA, United States
Support required risk assessments and document through appropriate risk management systems
Contribute to combination product technical documentation including design history file documents, design input requirements, test plans/protocol/reports, engineering assessments, and design outputs
Relevant Experience: 0 – 2 years post Master’s degree or 0 – 4 years post Bachelor’s degree.
Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment
Knowledge of statistical design of experiments (DoE) and analysis
Preferred: Experience in Biopharmaceutical, Pharmaceutical, or Biotechnology industry
Principal Research Associate, Drug Product Development
By Moderna At Norwood, MA, United States
Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projects
Exceptional laboratory skills and demonstrated knowledge in fill/finish unit operation characterization and scale up
Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.
Knowledge of GMP and GLP compliance
Family care benefits, including subsidized back-up care options and on-demand tutoring
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Specialist, External Operations, Drug Product
By Moderna Therapeutics At , Remote
Vacation, sick time and holidays
Volunteer time to participate within your community
Paid sabbatical after 5 years; every 3 years thereafter
Here’s What You’ll Bring to the Table:
Generous paid time off, including:
Manager, Drug Product Development And Manufacturing
By Avidity Biosciences At , San Diego, 92037, Ca $135,000 - $158,000 a year
Manage tech transfer activities between CMOs and/or within CMOs for scale-up of new or existing drug products.
Support process performance qualification studies and commercialization including secondary packaging.
Experience in GMP manufacturing required, along with strong understanding of US and EU regulations.
Experience working with third-party CMOs required.
Experience using statistical tools and software preferred.
Knowledge of cGMP, ICH, FDA, EMA guidelines regarding drug product supply.
R1556650 Associate Director, Drug Development Project Manager (Oncology) (Open)
By Bristol Myers Squibb At , Princeton, Nj
Experience with commonly used project management tools including but not limited to Microsoft project.
Excellent Project Management Skills – drives execution while balancing speed, quality, and cost.
Leadership skills including situational leadership, ability to lead a team of experts and influence without authority
Ability to resolve complex problems and manage difficult stakeholder situations
Accountable for creating and maintaining a cross-function development plan, timeline and budget for each program and ensuring progress vs. plan.
Proactively identifies risks and ensures mitigation plans are implemented
Pharma And Drug Delivery - Business Development
By Cambridge Consultants Ltd At , Boston, Ma
Feed back market information to the technical teams to support continuous improvement of our service offering
Compelling consultative selling skills to engage with customers
Excellent interpersonal, communication and presentation skills
To meet the requirements of this role you will be able to provide:
Successful applicant must comply with the federal contractor Covid-19 Workplace Safety mandate requirements.
Medical Devices – Advanced surgical tools; smart implants; robotics
Director Of Corporate Finance, Drug Development
By Labcorp At , Durham, 27703, Nc
10+ years of increasingly senior finance experience
CRO, investment banking, or experience in a financial leadership development program with a global company preferred
Demonstrated leadership and influencing skills
Excellent written and verbal presentation and communication skills
Responsibilities include, but are not limited to:
Lead the forecast, budget, and strategic planning processes across Drug Development FP&A
Manager Of Drug Product Manufacturing
By Resilience At , Alachua, 32615, Fl $105,000 - $135,000 a year
Preferred Experience, Education & Qualifications
Provides performance management guidance to staff as needed.
Provide other assistance as needed to upper Management.
Experience working as a team member with shared responsibilities is desired.
Order equipment and perform installation, qualification, and routine maintenance.
Resolves problems of manufacturing staff and manages manufacturing resources
Scientist, Drug Product Development
By Bristol Myers Squibb At , Summit, 07901, Nj
Knowledge in analytical method validation and knowledge of analytical method validation requirements as defined by ICH.
Experience with various analytical techniques including HPLC, Dissolution and KF. Experience with Capillary Electrophoresis is a plus.
Demonstrated problem solving skills and strong desire to grow scientifically.
Strong written and oral communication skills.
The Scientist will have interdepartmental responsibilities with regards to participating in workgroups, cross-functional teams, implementation/execution, and cultural initiatives.
Development of drug product analytical methods including chromatography-based methods such as HPLC/UPLC/SEC/GC, electrophoretic-based methods such as iCIEF/CGE/CZE, LC-MS, KF and Dissolution.
Associate Scientist, Drug Product Development
By Bristol Myers Squibb At , New Brunswick, 08901, Nj
Knowledge in analytical method validation and knowledge of analytical method validation requirements as defined by ICH.
Experience with various analytical techniques including HPLC, Dissolution and KF. Experience with Capillary Electrophoresis is a plus.
Demonstrated problem solving skills and strong desire to grow scientifically.
Strong written and oral communication skills.
The Associate Scientist will have interdepartmental responsibilities with regards to participating in workgroups, cross-functional teams, implementation/execution, and cultural initiatives.
Development of drug product analytical methods including chromatography-based methods such as HPLC/UPLC/SEC/GC, electrophoretic-based methods such as iCIEF/CGE/CZE, LC-MS, KF and Dissolution.
Associate Director Drug Product Development
By GSK At , Collegeville, 19426, Pa
Knowledge around current regulatory expectations and requirements to commercialize biopharmaceutical drug products including combination products.
Creative and motivated self-starter, with excellent verbal and written communication skills
Sound and timely decision-making and problem-solving skills in high impact situations
We are looking for professionals with these required skills to achieve our goals:
Take a lead role in drug product manufacturing process development, characterization, and tech transfer to GSK internal sites and/or external contractors.
Development of the drug product manufacturing control strategy, and authoring sections of regulatory submissions.

Are you an experienced drug product development professional looking for an exciting new challenge? We are looking for a Manager of Drug Product Development to join our team and lead the development of innovative drug products. You will be responsible for managing the development process from concept to commercialization, ensuring that all regulatory requirements are met. If you have a passion for drug product development and a drive to make a difference, this is the job for you!

Overview:

The Manager of Drug Product Development is responsible for leading the development of new drug products from concept to commercialization. This includes managing the development of new drug products from concept to commercialization, including the design, development, and validation of drug products. The Manager of Drug Product Development will also be responsible for ensuring that all regulatory requirements are met and that the drug product meets all quality standards.

Detailed Job Description:

The Manager of Drug Product Development is responsible for leading the development of new drug products from concept to commercialization. This includes managing the development of new drug products from concept to commercialization, including the design, development, and validation of drug products. The Manager of Drug Product Development will also be responsible for ensuring that all regulatory requirements are met and that the drug product meets all quality standards. The Manager of Drug Product Development will also be responsible for managing the development team, providing technical guidance, and ensuring that all project timelines are met.

What is Manager Of Drug Product Development Job Skills Required?

• Strong knowledge of drug product development processes and regulatory requirements
• Excellent project management skills
• Excellent communication and interpersonal skills
• Ability to work independently and in a team environment
• Ability to manage multiple projects simultaneously
• Ability to work in a fast-paced environment

What is Manager Of Drug Product Development Job Qualifications?

• Bachelor’s degree in a related field
• 5+ years of experience in drug product development
• Experience with regulatory requirements and quality standards
• Experience with project management
• Knowledge of cGMPs

What is Manager Of Drug Product Development Job Knowledge?

• Knowledge of drug product development processes and regulatory requirements
• Knowledge of cGMPs
• Knowledge of project management
• Knowledge of quality standards

What is Manager Of Drug Product Development Job Experience?

• 5+ years of experience in drug product development
• Experience with regulatory requirements and quality standards
• Experience with project management

What is Manager Of Drug Product Development Job Responsibilities?

• Lead the development of new drug products from concept to commercialization
• Manage the development team, providing technical guidance
• Ensure that all regulatory requirements are met and that the drug product meets all quality standards
• Ensure that all project timelines are met
• Manage multiple projects simultaneously
• Work independently and in a team environment
• Work in a fast-paced environment