Entries tagged with “process” from BiotechPharmJobs.com

Job Description:

Job Title: QC Associate I
Location: South San Francisco, CA
Recruiting Firm: Q Analysts

Q Analysts is looking for an QC Associate I for one of its client's located in South San Francisco, CA.

Responsibilities:

• Sharing responsibilities for routine lab operation and maintance.
• Perform general wet chemistry assays such as pH determination, total organic carbon (TOC), and protein concentration by UV spec scan and endotoxin detection by LAL testing.
• Routine support of the Quality Control sample management process.
• Daily duties and responsibilities would include sample receipt from manufacturing, log in, verification, sample handling and internal transfer within QC.

Skills:

• Ability to work well with others in a positive and collaborative manner. Computer literacy and experience working in a cGMP environment are preferred, but not required.
• Understanding of analytical techniques cited above is required.
Education:

• BS/BA in Biochemistry, Chemistry or related field

To apply, please send your MS Word resume along with salary requirements to:
mmathews@qanalysts.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Sr. Tech Manager
Location: South San Francisco, CA
Recruiting Firm: Q Analysts

Q Analysts is looking for an Sr. Tech Manager for one of its client's located in South San Francisco, CA.

The purpose of this position is to provide quality oversight and expertise for the selection, implementation and management of manufacture of small molecule API and Drug Product at contract manufacturing organizations.

Responsibilities:

• Build strong relationships with both internal operations units and external CMOs and partners.
• Participate in due diligence visits to assess CMO's Quality Systems for processing of investigational / commercial medicinal products.
• Negotiate and maintain Quality Agreements with selected CMOs and ensure the requirements of the Quality Agreement are fulfilled. Ensure product-specific requirements are met.
• Ensure that manufacture and testing of clinical supplies of the client's small molecule & ADC products at contract manufacturing organizations (CMOs) is conducted in accordance with cGMP.
• Follow up on any corrective actions identified as a result of the client's audits.
• Write and execute CMO facility/process GMP commissioning plans to ensure all quality requirements are met prior to manufacturing.
• Review and approve master batch records for compliance to clinical trial protocols, regulatory filings, pertinent product requirements and cGMP compliance.
• Perform person-in-the-plant activities as required during GMP manufacturing.
• Review batch records and assess deviations and investigations.
• Review CMC sections of regulatory filings.
• Participate in the design, implementation and maintenance of quality systems for small molecules for execution of the above functions.

Skills:

• Demonstrated working knowledge of Quality Assurance and manufacturing principles.
• Sound knowledge of US cGMPs and an ability to apply sound judgment and decision-making skills in order to evaluate product release is necessary.
• Working knowledge of worldwide cGMP regulations desired.
• Excellent written and verbal communication skills.
• Strong interpersonal skills and negotiation skills.

Education:

• At least 5 to 10 years relevant pharmaceutical experience with small molecules, experience in solid dosage form manufacturing is desired.
• At least 4 years direct experience in quality assurance for pharmaceutical operations.
• BS/BA in a relevant scientific discipline or equivalent

To apply, please send your MS Word resume along with salary requirements to:
mmathews@qanalysts.com

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Job Description:

Job Title: Data Solutions Engineer
Location: San Francisco, CA
Length of Contract: 1 Year


eDynamic is looking for Data Solutions Engineer in San Francisco, CA. The Production Data Solutions Engineer is primarily responsible for designing, implementing and maintaining the Production information systems used to support FDA regulated biopharmaceutical manufacturing operations. The successful Consultant will:

• Lead the development of web-based data visualization tools using industry standard technologies such as ASP.NET, xMII, and Microsoft SharePoint.
• Provide tools to access manufacturing data from a variety of database and non-database sources to the entire Production Technology Group.
• Participate in the design, installation and testing of validated and non-validated computer information systems.
• Maintain manufacturing-related information systems, including data and batch historians, process dashboards, and provide technical support as needed.
• Ensure that work conforms to cGMP standards and all applicable codes and regulations from the CFR, Annex 11 and OSHA.

Requirements:

• 4+ years of Biotech/Pharma experience
• Knowledge of computer systems, relational databases, and experience utilizing Windows, the .NET Framework, PL/SQL, ASP.NET, C#, and/or relational databases to build software solutions.
• Experience with SAP, SAP xMII (formerly Light hammer), MES, InfoPlus.21, and IronSpeed software
• Working knowledge of SCADA software and programmable controllers for process control applications, redundant and high reliability computer and network hardware systems, programming language experience, or an understanding of biopharmaceutical process manufacturing.

To apply, please send your MS Word resume along with salary requirements to:
birendra.kumar@edynamic.net

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Process Development Scientist - Protein Purification

Urgent requirement for one of our top clients located in Redwood City, CA.

Description:
The position will require hands-on work developing downstream processes, tech transfer of processes to CMOs and on- site interactions and management of CMOs to facilitate scale-up and clinical/commercial production. The incumbent will be responsible for developing, scaling up, & improving downstream processes in collaboration with external parties and the internally with the Protein Analysis group. The position requires the ability to develop and optimize downstream processes in accordance with regulatory requirements and the company's timelines for Phase III/commercialization. The individual will also be responsible for identification and implementation of improved technologies for R&D and commercial manufacture to enhance product quality, manufacturing cost efficiencies & regulatory compliance. The position is likely to require the management and training of junior staff.

Requirements:
Ph.D in Biochemistry or Biochemical Engineering with emphasis on Protein Purification and 5+ years of experience; or MS in Biochemistry or Biochemical Engineering with emphasis on Protein Purification and 10 plus years of relevant industrial experience. Experience in optimization and scale up of protein refolding from E. coli is a plus. Prior experience with various PEGylation methods at small and large scale is preferred.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. PDS_1508, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.