Bilingual (English & Chinese) Project Coordinator/Manager - CDMO Service
Germantown, Maryland, United States · On-site
$60k–$100k/yr
Mid level$95M raised
Position Summary: We are seeking an individual with a strong background in viral vector production and/or project management. This position reports to VP of Commercial StrategyProvide project management support to CMC te…
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$60k–$100k/yr
Full-time
bachelor degree, postgraduate degree
Posted 4d ago
Apply by Oct 22
~40 hrs/week
Responsibilities
The role involves providing project management support for CMC teams to ensure the successful manufacturing and release of drug substances and products. The coordinator serves as the primary liaison between the company and clients, managing schedules, communication, and regulatory documentation.
Requirements
Candidates must have a B.S. or M.S. in engineering or biological sciences and over 3 years of experience in biologics manufacturing, specifically viral vector production. Proficiency in MS Project and bilingual skills in English and Chinese are preferred.
Full job description
Position Summary: We are seeking an individual with a strong background in viral vector production and/or project management. This position reports to VP of Commercial Strategy
Provide project management support to CMC team members including PD, TT and GMP teams in their execution of activities including manufacturing and release of drug substance and drug product, manufacturing process improvements and validation, analytical method development, transfer and validation, and shipping studies.
Serve as the primary liaison between uBriGene and clients on CMC activities for the client projects.
Collect updates on all CMC activities in the MS Project file on a monthly basis to update % completion or new dates.
Schedule, conduct, and draft minutes for PD, TT and GMP team on respective client projects to ensure regular, efficient team, and stakeholder communication.
Facilitate robust communication within PD, TT and GMP teams to ensure all functions are aware of the schedule, changes in strategy and impacts to risks and resources.
Hold team members accountable for on-time completion of tasks or milestones.
Performs critical path analysis and supports scenario planning for CMC deliverables.
Provide project coordination and communication, including participation in technical calls and face-to-face meetings, development of agendas, creation of meeting minutes, tracking of action items, and scheduling of follow-up meetings.
Support writing, review, and schedule of CMC related regulatory documents and health authority interactions.
Assist in preparing presentations, updating corporate project plans, etc.
Other responsibilities as needed
II. Requirements
Education, Experience, and Skills
B.S. or MS. in engineering or biological sciences degree is required
> 3 years of experience in biologics manufacturing, preferably in viral vector production
Previous project management experience in the biologics production is preferred but not required.
Proven experience organizing, planning, and executing large-scale projects from vision through implementation
Experience using project management tools (project scheduling and resource management), such as MS Project.
Proven analytical, conceptual and problem solving skills are required to evaluate business problems and apply knowledge to identify appropriate solutions.
Exceptional team building and stakeholder relationship management skills are required, with the ability to establish rapport, persuade and effectively negotiate with senior management, key stakeholders and functions.
Bilingual skills in English and Chinese are preferred.
uBriGene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.
Your Bridge from ATMPs Concept to Commercialization
Industry
Biotechnology
Company size
11-50 employees
Founded
2015
Headquarters
Germantown, Maryland
LinkedIn followers
3,040
Total funding
$95M
uBriGene Biosciences is your bridge from ATMPs concept to commercialization. Our CDMO+ services include cell therapy products (CAR-T, TCR-T, NK Cells, iPSC, Dendritic cells, Macrophages), viral vectors (AAV, LVV, RVV, AdV, oncolytic viruses), plasmids, and RNA (mRNA, circRNA, acRNA).
Our extensive experience in manufacturing, QC testing, and regulatory filing support of ATMPs, from early discovery to commercialization, will accelerate your therapeutic programs from bench to bedside.
With four Centers of Excellence in North America, and Asia Pacific and more than 20 GMP clean room suites, uBriGene supports global CGT, vaccine, and RNA product development.
Offices: 20400 Century Blvd, Germantown, Maryland 20874, US · 13351 Commerce Pkwy, 1255, Richmond, British Columbia V6V 2X7, CA
iPSC Reprogramming RNA-LNPiPSC BanksAAV / LVV Helper PlasmidsCas9 Proteins / mRNAiPSC / MSCAnalytical development and testingAseptic fill and finishClinical applicationsCRO services (PlasmidsViral vector
Your Bridge from ATMPs Concept to Commercialization
Industry
Biotechnology
Company size
11-50 employees
Founded
2015
Headquarters
Germantown, Maryland
LinkedIn followers
3,040
Total funding
$95M
uBriGene Biosciences is your bridge from ATMPs concept to commercialization. Our CDMO+ services include cell therapy products (CAR-T, TCR-T, NK Cells, iPSC, Dendritic cells, Macrophages), viral vectors (AAV, LVV, RVV, AdV, oncolytic viruses), plasmids, and RNA (mRNA, circRNA, acRNA).
Our extensive experience in manufacturing, QC testing, and regulatory filing support of ATMPs, from early discovery to commercialization, will accelerate your therapeutic programs from bench to bedside.
With four Centers of Excellence in North America, and Asia Pacific and more than 20 GMP clean room suites, uBriGene supports global CGT, vaccine, and RNA product development.
Offices: 20400 Century Blvd, Germantown, Maryland 20874, US · 13351 Commerce Pkwy, 1255, Richmond, British Columbia V6V 2X7, CA
iPSC Reprogramming RNA-LNPiPSC BanksAAV / LVV Helper PlasmidsCas9 Proteins / mRNAiPSC / MSCAnalytical development and testingAseptic fill and finishClinical applicationsCRO services (PlasmidsViral vector