SUPERVISOR – REAGENT MANUFACTURING
SUPERVISOR – REAGENT MANUFACTURING

Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology and tissue-based

diagnostics. Our core RNAscope® technology is the world’s first multiplex fluorescent and chromogenic in

situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule

sensitivity. RNAscope® is an ideal platform for developing the next generation of tissue-based companion

diagnostics. We are committed to continued innovation to bridge the gap between basic research and clinical

medicine to fulfill the promise of personalized medicine.

POSITION DESCRIPTION

We seek a highly motivated and dynamic individual to join our Operations team as a Supervisor - Reagent

Manufacturing. An ideal candidate will be someone who is comfortable working in a fast-paced start-up

environment, but who also has an understanding in delivering quality products to the market place. This

person must be willing to learn new techniques quickly and be able to adapt to shifting priorities in a fast-

paced and dynamic environment. The responsibility of this position is to coordinate manufacturing activities

within their area of responsibility and be accountable for the proper training and development of team

members.

2017 February 20

Education Experience

  •  A B.S. or M.S. within molecular biology, biochemistry, cell biology or related field with at least 4 years of industry experience
  • Must have demonstrated good biochemical laboratory skills
  • Able to work in cross functional team environments
  • Able to generate results and perform work with minimal supervision
  • Previous experience with ERP System preferred
  • Experience in ISO 13485 and GMP environment a plus
  • Candidate must be a strong team player, self-motivated and willing to learn new techniques and concepts in a fast paced environment
  • Strong organizational skills and attention to detail
  • Excellent verbal and written communication skills
  • At least 1 year in a lead or supervisory role

Duties and Responsibilities

  • Ensure execution of manufacturing activities in strict accordance with manufacturing batch records,standard operating procedures, and ACD policies
  • Ensures adherence to ISO 13485 at all times and GMP standards where appropriate
  • Coordinates manufacturing activities with formulation and filling groups to ensure the manufacturing schedule is on time
  • Ensures accurate accounting of inventory in area of responsibility
  • Escalates manufacturing issues related to personnel, procedures, materials, process, equipment, etc to Manufacturing Management and/or appropriate functional area(s)
  • Oversees and evaluates the performance of subordinates; ensures operators are properly trained and training is documented and current
  • Responsible for the editing and accuracy of MPRs, work instructions and SOPs relevant to area of responsibility through the document control process
  • Assists in process scale-up to transition from pilot lots to full production-scale manufacturing
  • Ensures that equipment is monitored, maintained, and within calibration and that new equipment is processed according to ISO 13485 standards
  • Review of batch records in area of responsibility
  • Resolve NCPs in area of responsibility

Occasional Duties and Responsibilities

  • May participate in Process Changes and Planned Deviations
  • May participate in the manufacture and/or formulations activities to meet deadlines
  • May assist in transferring processes from development to manufacturing
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Advanced Cell Diagnostics

Our new headquarters office starting May 2016:

7707 Gateway Blvd.  
Newark, CA 94560
Toll Free: 1 (877) 576-3636
Phone: (510) 576-8800
Fax: (510) 576-8798

 

Advanced Cell Diagnostics , S.r.l.

Via Calabria15
20090 Segrate (Milano) - Italy

Phone: +39.02.95360323
Fax: +39.02.95360992
For European orders: order_europe@acdbio.com

Advanced Cell Diagnostics China

Building 15, No. 26 Xihuan South Road
Beijing Economic-Technological Development Area
Beijing, China, Zip code: 100176

400-966-1796
info_china@acdbio.com
For general information: Leon Li lli@acdbio.com
Web: www.acdbio.com.cn

For general information: info@acdbio.com
For place an order: order@acdbio.com
For product support: support@acdbio.com
For career opportunities: hr@acdbio.com