Cmc Project Manager 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

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)

Supports the preparation, coordination, and management of regulatory agency inspections

Develop and deliver staff training on topics related to Quality, GxP Compliance, SOPs, and Risk Management as required

5 or more years working in GMP Quality Assurance/Management with a BA in a scientific field

Perform batch record and data review/approval. Prepares GMP batches for disposition and may perform batch disposition depending on experience.

Manages internal GMP shipment procedures and approves shipments where required

Responsible for oversight of the GMP QA Vendor Qualification and Audit Program

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.

A minimum of 7-10 years of professional work experience in CMC project management within the Biotechnology or Pharmaceutical field.

Establish and lead cross-functional teams in the operational management of CMC activities to support Atalanta’s pipeline.

Implement CMC project management best practices that optimize pharmaceutical development and analytical services within Atalanta

Ability to work independently and implement Project Management tools, methodologies, and best practices.

Experience with oligonucleotides and/or nucleic acid therapeutics is a plus.

In-depth knowledge of chemical synthesis, process development, analytical development, and quality control concepts

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

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.

Microsoft Project (or equivalent project management software) and Microsoft Office skills

At least 2-years of experience as a project manager

10-years of experience in the Pharmaceutical, Biotechnology or Biomedical related field, direct CMC experience is highly desirable

Facilitation and soft skills to work with cross functional teams

Critical thinking and problem-solving skills

Develop and use project plans and schedules to measure and report progress.

Strong track record in executing effective program management skills in cross-functional matrix organizations.

Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.

Provides key updates on program risks, progress and mitigation plans to management as needed.

Responsible for program/project level budgeting and resource management

Leads operational project management for CMC alliance or co-development programs, including contributing roles on alliance sub-committees and steering committees.

Prepares and manages governance interactions in partnership with the CMC Lead.

2+ years of CMC Program Management experience in biomedical industry. Cell/gene therapy preferred.

Experience working with project management tools such as MS Project, MS Teams, MS Excel or Think-Cell; Smartsheet experience a bonus

Own the CDMO project management relationship and support tech transfer and CDMO management with LETI and ElevateBio Base Camp SMEs

1-2+ years of experience working with FDA- and/or EU-regulated Quality systems

Strong communication skills with ability to build professional relationships with external and internal stakeholders a must

SAP experience or similar ERP system is preferred

Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings

Job Title: CMC Project Manager - Remote

Establish and manage collaboration and team sites. Track delivery and create repositories for all PD deliverables

Assist PD in driving decision making and communication

Pay Rate: $70/hr to $75/hr

Apply project management expertise across the portfolio for standard and complex projects, managing multiple projects in parallel.

Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.

Report on project progress, offer viable solutions and opportunities as they arise

Work with internal and external stakeholders to manage project deliverables, e.g., CMOs, Supply Chain, etc.

Excellent interpersonal, communication, and presentation skills.

Strong leadership skills and executive presence; ability to positively influence outcomes.