Location: Lancaster, Pennsylvania, United States
Company Description:
At S1Medsearch we are career professionals dedicated to Blue Chip talent acquisition in the medical device and biotech industries. NOT ALL POSITIONS ARE ADVERTISED. If the above opportunity or location is not appropriate for you, please provide your resume with requirements for confidential consideration. All qualified applicants will be responded to within 48 hours.
Job Description:
Analytical Gurus!! Opportunity knocks with our growing pharma/device client offering state of the art technology development and manufacturing facilities!
Our firm specializes in medical technical recruitment and we are contracted to locate a superior Pharmaceutical Analytical Manager to be based in the Tri-City area west of Philadelphia, PA.
Reporting to the executive level, you will develop and lead the analytical department while responsible for accelerating the process of designing and obtaining regulatory approval for drug delivery applications for use with unique therapeutic compounds. You will be a key technical representative to the customer base.
KEY RESPONSIBILITIES:
• Identification, quantification, and characterization of extractables and leachables.
• Stability testing and characterization of drug products
• Identification and quantification of particulates, their effect on drug products, immunogenicity, and clinical impact.
• Characterization of large molecule aggregation on fluid path and particulate surfaces.
• Characterization of fluid mechanics on the integrity and stability of molecules.
• Expert knowledge in liquid drug formulation, dosing, dose accuracy, viscosity and fluid dynamics.
• Method validation for detection of leachables in placebo or drug products based on recommended industry practices and the International Conference for Harmonization (ICH) Guidelines.
• Characterization method and test method development.
• Improvement of containment and delivery systems for biologics.
• Strong customer-facing and interpersonal skills.
EDUCATION REQUIREMENTS:
Ph.D. in biophysics, analytical chemistry, biochemistry, chemical engineering or a related field is required.
PROFESSIONAL EXPERIENCE AND QUALIFICATIONS
• 7+ years of experience with a pharmaceutical, drug or drug delivery technology manufacturer or with formulation groups or contract manufacturers that specialize in liquid dose forms.
• Ability to create a vision of the future for pharmaceutical analysis and technology operations (5 to 10 years out) and to persuasively articulate such a vision.
• Technical and scientific expertise in the characterization of recombinant proteins, monoclonal antibodies, vaccines, and gene therapy vectors.
• Engineering expertise in functional performance testing of drug delivery devices.
• Must have experience in the use of the following types of equipment and techniques:
Liquid Chromatography Mass Spectrometry (LC/MS)
Gas Chromatography Mass Spectrometry (GC/MS)
Inductively Couple Plasma Spectroscopy (ICP)
Fourier Transform Infrared spectroscopy (IR)
High-Performance Liquid Chromatography (HPLC)
At S1Medsearch we are career professionals dedicated to Blue Chip talent acquisition in the medical device and biotech industries. NOT ALL POSITIONS ARE ADVERTISED. If the above opportunity or location is not appropriate for you, please provide your resume with requirements for confidential consideration. All qualified applicants will be responded to within 48 hours.
Job Description:
Analytical Gurus!! Opportunity knocks with our growing pharma/device client offering state of the art technology development and manufacturing facilities!
Our firm specializes in medical technical recruitment and we are contracted to locate a superior Pharmaceutical Analytical Manager to be based in the Tri-City area west of Philadelphia, PA.
Reporting to the executive level, you will develop and lead the analytical department while responsible for accelerating the process of designing and obtaining regulatory approval for drug delivery applications for use with unique therapeutic compounds. You will be a key technical representative to the customer base.
KEY RESPONSIBILITIES:
• Identification, quantification, and characterization of extractables and leachables.
• Stability testing and characterization of drug products
• Identification and quantification of particulates, their effect on drug products, immunogenicity, and clinical impact.
• Characterization of large molecule aggregation on fluid path and particulate surfaces.
• Characterization of fluid mechanics on the integrity and stability of molecules.
• Expert knowledge in liquid drug formulation, dosing, dose accuracy, viscosity and fluid dynamics.
• Method validation for detection of leachables in placebo or drug products based on recommended industry practices and the International Conference for Harmonization (ICH) Guidelines.
• Characterization method and test method development.
• Improvement of containment and delivery systems for biologics.
• Strong customer-facing and interpersonal skills.
EDUCATION REQUIREMENTS:
Ph.D. in biophysics, analytical chemistry, biochemistry, chemical engineering or a related field is required.
PROFESSIONAL EXPERIENCE AND QUALIFICATIONS
• 7+ years of experience with a pharmaceutical, drug or drug delivery technology manufacturer or with formulation groups or contract manufacturers that specialize in liquid dose forms.
• Ability to create a vision of the future for pharmaceutical analysis and technology operations (5 to 10 years out) and to persuasively articulate such a vision.
• Technical and scientific expertise in the characterization of recombinant proteins, monoclonal antibodies, vaccines, and gene therapy vectors.
• Engineering expertise in functional performance testing of drug delivery devices.
• Must have experience in the use of the following types of equipment and techniques:
Liquid Chromatography Mass Spectrometry (LC/MS)
Gas Chromatography Mass Spectrometry (GC/MS)
Inductively Couple Plasma Spectroscopy (ICP)
Fourier Transform Infrared spectroscopy (IR)
High-Performance Liquid Chromatography (HPLC)
Company Name: S1Medsearch
