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Company

Original Job Post

BioSpace · 1 day ago

Senior Manager, CMC Project Management

Emeryville, CA

Full-time

Onsite

Senior Level

$153K/yr - $198K/yr

8+ years exp

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Comp. & Benefits

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Responsibilities

Manage internal CMC project's scope, timelines, budget, risks, and documentation of meetings

CDMO project management includes processing various legal documents and contracts needed to work with CDMOs.

Identify project risks and proactively facilitate mitigation strategies and resolution.

Ensure relevant communication and alignment across CMC departments as appropriate.

In collaboration with Tech Ops leadership, create mid- and long-term project strategies and help determine the CMC needs of programs alongside CMC and similar colleagues.

Responsible for ensuring flawless and smooth execution of CMC deliverables according to defined timelines and cost via leading multidisciplinary CMC teams as well as preparing accurate CMC updates for key stakeholders, including the Executive Team.

Effectively present information, respond to questions and facilitate communications regarding CMC updates, program risks, and business impacts across the organization when required.

Support development, implementation, and adherence to operational procedures throughout the organization.

Other duties as assigned: nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Biologics manufacturingProcess developmentCGMP manufacturingProcess registrationAnalytical scienceViral vector productionCMC project managementCMC projects managementCMC projectsTechnical experienceRecord of accomplishmentPersonnel managementHigh morale maintenanceSenior stakeholdersMicrosoft ProjectMicrosoft TeamsAutomated presentationsIntegrated drug development processesBiopharmaceutical companyGene therapy programsCell therapy programsWork stream managementProject managementComplex information communicationProblem-solvingLeadershipMotivationalCommunicationIndependencePragmatic

Required

Bachelor’s degree in life sciences or a relevant field. Advanced degree in life sciences preferred.

8+ years of hands-on technical experience in biologics manufacturing or development (e.g., process development, cGMP manufacturing, process registration, analytical science), preferably in viral vector production, preferred

5 + years of experience in CMC project management

Record of accomplishment of successfully managed CMC projects and personnel

Leadership and motivational soft skills to maintain naturally high morale within the CMC team

Ability to communicate effectively at all levels across the organization. Has strength of character to have difficult conversations with senior stakeholders, including customers, internal team members, and senior management; excellent written, verbal, and presentation skills

Ability to function independently in a fast-paced environment.

Pragmatic, organized, and results-oriented and with the ability to manage multiple priorities

Excellent planning, organizational, and controlling skills

Problem-solving skills - ability to analyze using critical thinking and solve complex issues that do not have routine solutions and propose solutions

Skilled with Microsoft Project, Teams, and other automated presentations

Must have sound knowledge of integrated drug development processes in a biopharmaceutical company. Experience with gene or cell therapy programs preferred.

Ability to manage multiple work streams and projects concurrently.

Excellent interpersonal and communication skills, both written and oral, and ability to communicate complex information succinctly.

Preferred

Advanced degree in life sciences

Experience with gene or cell therapy programs

Company

BioSpace

BioSpace is the leading online community for industry news and careers for life science professionals.

Founded in 1988

San Francisco, California, USA

11-50 employees

http://www.biospace.com/

H1B Sponsorship

BioSpace has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2020 (2)