Careers



Collidion, Inc. and its subsidiaries,
Plex Pharmaceuticals & Avenlogics, Inc.


Founded in 2015, Collidion, Inc. is a private healthcare company with two subsidiaries, Avenlogics, Inc. and Plex Pharmaceuticals. Collidion strives to improve the future of global healthcare through the acquisition, licensing, development, and commercialization of drugs and medical devices for various markets.  Collidion invests industry expertise and capital to develop these technologies into recognizable solutions for patients and medical professionals. Collidion values innovation, scientific rigor, collaboration and a passion for change.
 
Avenlogics, Inc., Collidion’s subsidiary, is focused on the development and commercialization of several anti-infective based products.  The Company’s pipeline of antimicrobial products addresses a growing need for alternative therapies to effectively treat infections caused by antimicrobial resistant pathogens. Collidion’s solutions include several antimicrobial platforms with potential applications in human and animal medicines, wound care, surface disinfection, and improved safety for the food supply chain. The company is located alongside with Collidion, Inc in Petaluma, CA.
 
Plex Pharmaceuticals is a scientifically-driven company with a vision to improve the lives of patients with complex diseases and conditions. The company is focused on the treatment of diseases generally caused by protein misfolding: ALS, Parkinson’s disease, and cataracts.  The company was founded in 2009.  Plex has a rich pipeline of drug discovery programs and a dedicated scientific team. Plex’s drug discovery lab and operations are located in San Diego, California.


Pharmaceutical & Medical Device Regulatory Affairs Director


Position: Full-time
Location: Flexible
To apply, visit www.collidion.com/careers 
  
PHARMACEUTICAL AND MEDICAL DEVICE REGULATORY AFFAIRS DIRECTOR
 
   Regulatory representation and leadership to cross-functional product development teams, development of regulatory strategies and support for clinical and non-clinical development programs and marketing applications. 
   Responsible for project timelines and management of 510K, PMA, IND, NDA and global regulatory submissions. 
   Lead regulatory activities including planning and reviewing of CMC, clinical and nonclinical sections of regulatory submissions. 
   Plan, direct and prepare regulatory submissions (IND, NDA, IDE, 510(k), PMA) to ensure compliance with FDA and international regulations and guidelines. 
   Develop and maintain SOPs with an emphasis on drug and device regulations. 
   Perform research regarding regulatory strategic recommendations, and new and revised governmental regulations. 
   Conduct successful negotiations and interactions with domestic and foreign regulatory agencies on assigned projects. 
   Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials. 
   Prepare and assist with applicable regulatory audits. 
   Statistical techniques. 
 
 
EDUCATION REQUIREMENTS:  
 
   Minimum of B.S. in life sciences, engineering, or equivalent required. 
   Advanced degree preferred. 
 
 
EXPERIENCE REQUIREMENTS: 
 
    Minimum 5-7 years of experience in regulatory affairs for pharmaceutical and medical device biopharmaceutical companies. 
   Veterinary product experience highly desirable. 
   Experience with successful FDA and international agency negotiations and audits. 
   Experience in developing and submitting successful 510(k), PMAIND/NDA submissions with a thorough understanding of the drug and device development processes, FDA regulations and ICH guidelines. 
   Excellent verbal and written communication skills. 
 
 
OTHER QUALIFICATIONS: 
 
   Detail oriented with well-developed organizational and analytical skills. 
   Experience with submitting documents in CTD and eCTD format. 
   Suited to working in a fast-paced, small company environment. 


Director of Pharmaceutical & Medical Device Quality Assurance


Position: Full-time
Location: Petaluma, CA
To apply, visit www.collidion.com/careers
    
PHARMACEUTICAL AND MEDICAL DEVICE QUALITY ASSURANCE DIRECTOR
 
   Lead a QA team to develop, direct and maintain a cGMP compliant quality system throughout the company.
   Effectively analyze, develop and implement systems, processes and equipment in compliance with ISO and FDA requirements.
   Direct internal and external audits.
   Develop and implement quality control process sampling systems, procedures, and statistical techniques. 
   Maintain and direct all cGMP/ISO Quality Assurance related requirements and responsibilities. 
   Support the CAPA process, collaborate with owners to ensure effective root cause analysis and the development of innovative, long-term solutions. 
   Maintain metrics for quality systems including supplier quality, non-conformances, and CAPA. 
   Tracks the effectiveness of corrective action plans and compliance improvement initiatives. 
   Responsible to review and establish quality goals within the company on an annual basis.
   Experience with Design Control (i.e. Design input/output),
   Experience in leading new validation activities for processes, products and engineering.
   Experience in the development of a design master file, FMECA and PFMECA
   Experience with test method validations.
   Experience working across different department teams such as: QA, QC, Regulatory, Manufacturing, Inventory, Marketing.
 
 
EDUCATION REQUIREMENTS:  
 
   Minimum of B.S. in life sciences, engineering, or equivalent required. 
 
 
ADDITIONAL EXPERIENCE REQUIREMENTS: 
 
   Minimum 7-10 years of experience in Quality Assurance for pharmaceutical and medical device biopharmaceutical companies. 
   Experience with successful FDA and international agency negotiations and audits. 
   Excellent verbal and written communication skills. 
 
 
OTHER QUALIFICATIONS: 
 
   Detail oriented with well-developed organizational and analytical skills. 
   Experience working in a fast-paced, start-up environment a plus.

Research Associate, Biology


Position: Full-time
Location: San Diego, CA
To apply, please submit Resume/cover letter to hr@plexpharma.com

The successful candidate will contribute to drug discovery efforts by performing compound screening in biochemical and cell-based assays, as well as assisting in assay development for further characterization of compounds. Under supervision the Research Associate will:

  • Use appropriate cellular models for neurodegenerative and other diseases for assaying cell death, neuroprotection, and biomarker assays
  • Perform enzyme assays, binding assays, reporter assays, SDS-PAGE, Western blot analysis, and ELISAs
  • Develop and troubleshoot new cell-based and biochemical assays
  • Identify and develop strategies to contribute to drug discovery projects and grant applications
  • Support day-to-day needs of the lab and company

Education Qualification and Experience:

Plex is a casual, friendly work environment with an attractive benefit package which includes: paid time off, company paid medical & dental plans.

Plex Pharmaceuticals is an EOE