Regulatory Cmc Jobs

Past Management Experience is a MUST

Will work and manage in-house and outsourced lab activities

Experience working amongst CMC leaders such as Regulatory, Analytical, and Quality

Experience overseeing outsourced vendors (CMOs/CDMOs)

Experience overlooking multiple drug candidates within the company's pipelines

M.S. or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 10-15 years of industry experience

Perform data transcriptions, method qualification, method trending, and light analysis on data received from external testing facilities

3+ years of industry experience

Experience in large molecule release such as protein concentrations, SE-HPLC, sterility, and endotoxin

Experience with pre-filled syringe testing

Experience with light analysis on CDMO provided data

Our client is seeking a Remote CMC Junior Data Analyst!

Develop and manage budgets for CMC operations, ensuring cost-effectiveness while maintaining high-quality standards

Forecast and manage the supply of drug product for clinical trials

A minimum of 10-12 years experience in pharmaceutical or biotechnology CMC development with regulatory interactions experience

Excellent cross-functional leadership, team building, and communication skills

Proven experience in tech transfer, manufacturing scale-up, and validation of biotechnology products

Hiring Manager Interview (45 minutes)

• 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)

Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.

Position functions autonomously and consults with departmental management on an as-needed basis.

Position is remote, but expected to be a normal office situation occurring during typical US business hours.

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership – Leveraging our collective expertise to connect people to products and services.

Clinical experience and great customer service skills.

Medical knowledge in pediatric patients and vaccines.

The LVN is responsible for the direct and indirect care of the clinic patients.

The LVN assists the physician and/or mid-level provider providing care to patients.

Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.

Position functions autonomously and consults with departmental management on an as-needed basis.

Position is remote, but expected to be a normal office situation occurring during typical US business hours.

Key responsibilities for this role include:

The minimum qualifications for this role are:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

· Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers

· Knowledge ofregulatoryguidelines and relevant applications.

· Demonstrate effective leadership, communication, interpersonal skills, and soft skills.

Inviting applications for the role of CMC 3 Manager-RegulatoryAffairs !

Qualifications we seek in you!

• Proven and relevantregulatoryaffairs experience in pharmaceutical, vaccine, or biological products; or related fields

Provides clear directions, delegates appropriately, communicate proactively, providing both project and people management skills.

Broadly skilled drug development scientist with evidence of strategic, tactical and operational abilities.

15+ years experience, in biologics drug development and manufacture

Knowledge of cGMP regulations, ICH guidelines, and the CMC content of global regulatory submissions

Substantial biotech/industry drug development experience is necessary, a track record leading process development and product supply activities for biologics.

Experience developing combination products such as autoinjector devices is desired.

Lead and manage multiple and concurrent drug substance projects, with responsibilities including:

Excellent written and oral communication skills, including experience in technical writing in support of regulatory submissions.

Good organizational skills and the ability to manage multiple competing priorities.

Lead and manage formulation development, which may entail one or more of

Experience working, collaborating with, and managing CDMOs.

Good knowledge of formulation options and troubleshooting

BS in a quantitative or scientific discipline with 4+ years of relevant data science/analytics experience in the pharmaceutical industry

Experienced with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data

Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire)

Prior experience working in a GMP environment and understanding of bioprocessing unit operations is a must

Drive and support data pipeline initiatives

Engage with the delivery of new process analytics tools cross-functionally

Project management experience with excellent interpersonal, presentation and communication skills.

Three or more years complex worldwide CMC regulatory strategies/requirements and demonstrated ability to influence the global internal/external regulatory environment. 

Two or more years of experience managing and directing multiple projects/teams in a high matrix environment.

One or more years of experience fulfilling a key role in major filing activities.

Experienced in supervising and training junior staff and the ability to motivate and lead others.

Managing the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.

8 to 12 years’ experience working in a regulated, life science environment with Strong project management interpersonal skills.

Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, Resource Forecasting.

Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines.

Responsible for Product lifecycle management & plan for global regulatory filings and assessments as required by the individual project.

Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements.

Should have demonstrated ability to manage the product life cycle submissions in key regulated markets like US, Canada, UK & EU.

Knowledge or experience with regulatory requirements in other regions and familiarity with GMP regulations is a plus.

In-depth knowledge of ICH requirements and regulatory requirements in the US/EU.

Proficiency in authoring complex technical documents, including CTD M2 and M3 sections, and life cycle management.

8+ years of experience in regulatory CMC within the pharmaceutical or biopharmaceutical industry.

Excellent oral and written communication skills are essential.

Detail-oriented, self-motivated, and comfortable handling broad responsibilities in an entrepreneurial, fast-paced environment.

Microsoft Project (or Smartsheet), PowerPoint, Excel skills are essential. SharePoint experience preferred

Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items

5 years of technical CMC small molecule experience in the biotechnology or pharmaceutical industry

Experience in a cGMP environment is required; drug substance and/or drug product manufacturing experience preferred

Excellent verbal and written communication skills. Demonstrated ability to influence peers and stakeholders in business and technical roles

This is a remote-based position located in the United States.

80% employer-paid MEDICAL HMO plan

80% employer-paid DENTAL PPO plan

We are in works to add 100% employer-paid Basic Life/AD&D + ST Disability

We will eventually also add a Medical PPO plan

Maintains current knowledge of regulations and guidelines (FDA, ICH, and others as required).

5-10 years experience in regulatory CMC

Coordinate and lead the task of drafting responses to CMC-related questions from FDA or foreign health authorities.

Work with functional groups to provide timely responses to CMC questions from regulatory authorities.

Coordinates activities for meetings with FDA and other regulatory authorities.

Coordinates with cross-functional teams to define contributions to submissions.

•Strong leadership qualities including strategic thinking, innovation, people management, project management and excellence in communication

Position - Senior Manager (SM) Regulatory Affairs CMC (Small molecules)

•Manage post approval changes where needed

Qualifications we seek in you!

•Prior experience in big (or mid-size) Pharma companies

•Robust communication and presentation skills

5-8 years pharmaceutical industry experience with 2+ years direct or related CMC regulatory experience

Basic knowledge of regulations/guidance documents and pharmaceutical development process.

Strong oral and writing skills. Able to compile early/simple submission under supervision.

B.S. in a scientific discipline, graduate degree in a scientific discipline preferred

Join a Legacy of Innovation 110 Years and Counting!

Participates with senior management to establish strategic plans and objectives.

Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization.

Directs the activities of a functional area or multiple integrated departments through lower management.

Ensures budgets and schedules meet corporate requirements.

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

Makes final decisions on implementation and ensures operational effectiveness.