Careers
Ceregene strives to develop and commercialize novel gene-based neurotrophic therapies that restore vitality and function to the nervous system in disorders for which significant unmet medical needs exist, such as Alzheimer’s and Parkinson's diseases. Success will be realized through our uncompromising commitment to three core areas:
- Patients-we work diligently to develop treatments that improve the quality of life for the millions of people affected by neurodegenerative diseases.
- Employees-we provide a dynamic, challenging work environment by offering opportunities for professional growth within the organization while also acquiring additional expertise as needed.
- Shareholders-we maintain efficiency in our operations and flexibility in our business strategies in order to maximize return on investments.
Ceregene is well-funded and looking for motivated, dedicated individuals with strong communication skills and the ability to work in a fast-paced, small company environment.
Clinical Project Manager/Sr. Manager - Job # 08-005
Ceregene has multiple products in clinical development including an ongoing phase 1 study in Alzheimer's disease and a controlled phase 2 study in Parkinson’s disease. Current opening would be primarily responsible for the Alzheimer's disease trial, for which there is a phase 2 in the planning stages.
The (Sr.) Clinical Project Manager serves as the liaison between Ceregene and contract research organization, field sites, investigators, study coordinators and staff members for specific project or study. Develops study related documents. Ensures compliance with study guidelines and timelines. Assists in review of study data.
Requirements include a bachelor’s degree, life sciences preferred, or equivalent, and relevant experience in biotechnology clinical operations with phase 2/3 trials. Experience with U.S. trials, European trials a plus. Excellent interpersonal communication skills; strong collaboration and teamwork orientation.
Clinical Project Specialist - Job # 08-004
Provides clinical study management support for clinical trial operations. Responsible for various activities related to assisting project managers, document control, tracking study activities, managing documentation, compiling study information, maintaining master files for all studies, and communicating with study sites to ensure each party has all relevant information, supplies and documentation.
Requirements include previous college level coursework required; bachelor's degree preferred. Previous experience with documentation in a biopharmaceutical environment, clinical operations experience preferred, including a variety of clinical trial documents. Good general administrative skills including experience setting up and maintaining paper and electronic filing systems. Must have very good interpersonal and written communication skills and be able to work independently as well as from a team perspective. Demonstrated organization and planning skills and attention to detail. Must be able to set priorities and work in a very fast paced company. Proficiency with computers, MS Office products preferred, particularly skill with Excel and WORD.
Document Control Specialist/Sr. Specialist - Job # 08-003
The Document Control Specialist/Sr. Specialist will be responsible for processing and controlling the storage of Quality Records which includes change requests, procedures, specifications, protocols, reports, drawings, electronic and hardcopy archives, and notebooks. They will interface directly with users of controlled documentation to ensure internal satisfaction and conformance to company requirements. Key day-to-day duties are routing and releasing controlled documents, maintain change control process including formatting as required, maintain manual and electronic logs. Ensures all Quality System records are controlled in a manner which ensures integrity and accessibility including photocopying/scanning of documents, as applicable.
The successful candidate will have a minimum of an AA degree or equivalent and 2 years document control experience for Specialist, 5 years experience for Sr. Specialist in the biotechnology/pharmaceutical/or medical industry. Must possess excellent interpersonal skills, a professional attitude, be able to work in a high-volume department and be able to work in a team environment. Microsoft Word, Excel and Access experience. Must be detail-oriented with good organization and time management skills.
Sr. Research Associate, Assay Development - Job # 08-002
The Sr. Research Associate, Assay Development is responsible for release testing in support of non-clinical and clinical viral vector products in compliance with GXP requirements. Develops, optimizes, modifies, and follows standard operating procedures (SOPs); performs release, stability, and in-process testing of materials, samples, and final products; works with mammalian cell cultures. Performs analysis and interpretation of test results, identifies deviations, and makes appropriate recommendations. Participates in methods and equipment qualification/validation studies; generates protocols, executes and coordinates experiments and drafts reports. Develops assays and performs testing to support nonclinical IND-path toxicology and biodistribution studies. Provides guidance to less experienced staff.
Requirements include a relevant scientific degree with minimum 5 years related experience in a bio-pharma analytical laboratory. Experience in assay development required. Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative PCR, ELISA, and cell-based assays. Proficient in general and non-routine laboratory skills. MS Office skills required. Experience in quality control strongly desired. Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries strongly desired. Experience with viral vector (adeno-associated virus) product is a plus. Good oral and written communication skills. Equipment related software such as Soft Max Pro desired.
Director/Sr. Director, Manufacturing - Job # 07-016
Oversees all aspects of Ceregene's manufacturing processes. Participates in planning the overall manufacturing strategy for product development for drugs and delivery devices, ensuring alignment with overall business strategy. Manages a team of five manufacturing and process development professionals in the planning and execution of manufacturing for advanced clinical trials. Manages the selection, contract, coordination with and performance of external CMO's. Plans and directs the technology transfer of products from research and development to international or domestic CMOs including process limits studies and process validation studies. Participates in regulatory strategy and planning, managing the CMC regulatory submission process.
Requirements include a degree (prefer Master's or Ph.D.) in a biological, chemical or biotechnology engineering or related discipline and 8 + years management experience in a cGMP pharmaceutical manufacturing environment with small and large scale cell culture, fermentation and/or purification and medical devices. Must have regulatory knowledge and experience dealing with regulatory agencies (FDA). Must have experience with CMO selection, contract negotiation, and management. Good leadership and people management skills, sound judgment, exceptional organizational and project management skills, and ability to multi-task and thrive in a fast-paced entrepreneurial environment. Flexibility and a positive, "can-do" attitude are necessary.
Quality Control Analyst - Job # 07-011
The Sr. Quality Control Analyst is responsible for release testing in support of non-clinical and clinical viral vector products in compliance with GXP requirements. Establishes, modifies, and follows standard operating procedures (SOPs); performs release, stability, and in-process testing of materials, samples, and final products; works with mammalian tissue samples and cultures. Performs analysis and interpretation of test results, identifies deviations, and makes appropriate recommendations. Provides guidance to junior staff and applies technical and regulatory compliance knowledge daily.
Requirements include a relevant scientific degree with minimum 5 years related experience in bio-pharma analytical laboratory. Experience in quality control strongly desired. Experience with viral vector (adeno-associated virus) product is a plus. Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries is required. Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative PCR, ELISA, and cell-based assays. Proficient in general and non-routine laboratory skills. Good oral and written communication skills. MS Office skills; equipment related software such as Soft Max Pro desired.
Ceregene is an equal opportunity employer. We offer a collegial, entrepreneurial working environment, excellent benefits, salary and stock options. For consideration, please submit your cover letter with job code and C.V. via fax or as an MS Word attachment to:
US Mail:
Ceregene, Inc. Human Resources
9381 Judicial Drive, Suite 130
San Diego, CA 92121
Facsimile:
Ceregene Human Resources
858.458.8801
E-mail
hr@ceregene.com
Your interest in Ceregene is sincerely appreciated.