Project Manager I

Location
San Diego, CA
Posted
Apr 18, 2018
Required Education
Bachelors Degree
Position Type
Full time

Let’s Make Things Happen!

 

Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.

 

Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.

 

Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.

 

Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.

 

Althea is currently seeking a Project Manager I responsible for project management tasks for custom manufacturing projects or fills that support key clients & internal objectives.  Under general supervision this position drives planning, decision-making, develops implementation strategies and lead efforts for projects. This position will work with team members to create and maintain project plans and timelines, which may include budget, definition, scope, project staffing, financial resources allocation, dependencies, and target dates. This position does not have direct supervisory responsibilities, but will lead cross functional internal/external project team activities. 

 

Responsibilities:

  • Manages technical, research level and GMP production projects governed by a contract between Althea and client including but not limited to: product/process transfers, API productions, Fill/Finish, Corynex, Crystalomics,.
  • Communicates effectively with client and across all functional groups so that schedules and scope of the project is clear.
  • Tracks and forecasts revenue generating activities. Works with finance to ensure invoices are accurate and paid on time.
  • Responsible for development of project timelines and tracking of contract deliverables (in Gantt charts or similar tool).
  • Responsible for assembling, analyzing and reporting project metrics for internal and external stakeholders.
  • Identifies project issues such as resource, technical or scheduling constraints and assists to resolve these issues internally and with external stakeholders by development of risk assessments, summarized options and proposed solutions with impact statements. 
  • Ensures that projects are completed on time, within budget and scope, and conforms to pre-established quality standards.
  • Responsible for hosting client on site visits.
  • Responsible for evaluating unexpected deviations that may impact project deliverables or timelines and taking steps to resolve these issues.
  • Ensuring that any quality issues are addressed by the quality group, including client complaints.
  • Assists with the development of project plans, monitors for accomplishment and profitability, closes projects, and provides summaries/feedback for proposed process changes.
  • Embodies Althea’s cultural values by aligning daily actions with department goals and company culture.
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

 

Requirements:

  • Bachelors’ or Master’s degree in a scientific or business discipline is preferred.
  • Minimum of one to five (1-5) years of biotechnology or pharmaceutical experience is required, CMO experience is preferred.
  • Minimum of one (1) year of related Project Management experience.
  • Regulatory experience preferred.
  • Understanding of biotech or drug product development and of multi-project planning and coordination is required.
  • Demonstrated leadership, interpersonal, matrix management, problem solving, and conflict resolution skills.
  • Must be able to prioritize and multi-task, work effectively with little or no direction, and build collaborative relationships with management, partners and peers from diverse backgrounds.
  • Strong computer skills, including MS-Project is preferred.
  • Excellent organizational and interpersonal skills. Strong verbal and written communication skills.
  • Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitment.

 

If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the "Careers" section.  Please be sure to note where you saw our ad posting.

 

We are an EOE dedicated to a diverse work force and Drug Free work environment.

Qualified M/F/D/V candidates are encouraged to apply.