TOP CANDIDATES
pHARMACEUTICALS, BIOTECH
& MEDICAL DEVICES

For the listings below, please contact Mike Hassell mikehassell@spassociates.com

  • Mgr. Analytical Services & Sr. Chemist – BS Molecular Biology. Seasoned professional with supervisory, audit, validation, quality and regulatory submission experience in cGMP environment.   A candidate who wears many hats and serves on many high-level committees within the company.   Developed leadership skills, proven ability to organize and schedule multiple projects under aggressive timelines, proven decision making skills, demonstrated ability to use good judgment, diplomacy, and maintain confidentiality.  Experience with the analytical oversight of product development from early phase to launch for multiple drug delivery platforms.  $100-110k.    85699   
  • Director Operations  & Tech Affairs – BS Biochemistry, MBA.  Leader who has produced exceptional results in mfg and supply chain operations.  Adept at aligning personnel and processes to achieve objectives. Led site transformation to “World Class Operations” using Lean concepts; increased biologics process output 30% in response to spike in demand.  Experience also in food and medical devices.     84482   
  • Sr. Validation Engineer:  Contract basis – MS Molecular Biology/Biochemistry/Microbiology.  Experienced in commissioning, qualification, quality assurance, and leadership in pharm. and medical device industries.  Led qualification and regulatory compliance of all areas of vaccine mfg. plant from master seed storage through filling and packaging.  Rate: $85 per hour.   85788  
  • Technical Services and QA Leader – BS Industrial Chemistry.  Progressive experience in pharmaceuticals, medical device, and biotech/biopharma.  Has managed QA Microbiology, QA release laboratory, and QA Systems (CAPA, nonconformance, change orders, document control).  Fluent in Spanish.  $120k  85787  
  • Senior Scientist – BS in Animal Production.   Skilled in drug discovery research. Well versed in development, validation, and optimization of complex analytical methods to investigate and advance chemical compounds.  Background in HPLC, GC/MS, LC/MS, and LC/MS/MS methodologies in both in vitro and in vivo experiments.  Numerous publications.    $75k       85748   
  •  Director – Bus. Development & Marketing – BS Recombinant Gene Technology, MS Molecular Biology, MBA.  Senior Scientist background w/ entrepreneurial instincts and skills in building business pipelines through direct sales, partnerships, & licensing.  Experience in mergers/acquisitions and raising capital.  $160k    85766  
  • Biomedical Lead Engineer – PhD ME,  BS Chem E.    Conducted biomedical research in academic and gov’t settings while procuring extramural funding.   Expertise is in instrument development, computer-aided design, mfg, and engineering (CAD, CAM, CAE), measurement science in biosystems, and toxicology screens.   85638.  
  • Microbiologist – BS Biotechnology (Microbiology).  14 years experience in pharm, medical device, consumer goods, and cosmetics industries.  Experienced in manufacturing, validations, and QC testing.  Knowledgeable in Celsis rapid detection system (bioluminescence technology) and Six Sigma Lean practices. Familiar with all regulatory guidelines for all testing and establishment of technical test procedures and methods.    85707
  • Computer Systems Validation Expert:  Contract basis- led integration of computer system validation activities for the start-up of new biotech mfg. facility.  Recent responsibilities were validation and delivery of regulated-based information systems in biological sample management, scientific data management, batch production, business analytics, and identity-access management.   Rate $75-80 per hour.    85749 
  • Supervisor of Chemistry – BS Chemistry.  10 years in pharm industry; 5 years in solid dosage.  Experience in HPLC, UV, FT-IR, Karl Fisher, DSC & TGA.  Supervises staff of 12.  Conducted laboratory investigations, training of chemists in mfg. and QC environments, analytical research, and QC testing of raw material, in-process, finished product, and stability testing.  $85k    85623   
  • Science Officer - Ph.D. Analytical Chemistry,  MBA.  Versatile executive who can head up the scientific engineering and development functions, lead in commercial scale-up, or direct a pilot plant or mfg. organization.  Experienced in managing, organizing, and supporting innovation of new products, processes, and mfg. support devices.    85651  
  • Operations & Supply Chain - BS ME, MBA.  Developing supply chain for medical device and instrumentation.  Led qualification of new suppliers for motors, valves, pumps, etc., which resulted in hundreds of thousands of dollars  in savings via alternate sourcing.  Very knowledgeable about technical aspects; has managed machine shop and engineering departments of medical equipment manufacturer.         $120+bonus     85666      
  • Manufacturing Manager – BS ChEInternationally experienced professional specializes in optimizing mfg. operations through continuous improvements, employee development, and leadership.  Ran all aspects of CMO producing excipients and API for pharmaceutical, biotechnology, veterinary, and cosmetics industries.    5704
  • Sr. QA Validation – medical devices and pharmaceuticals.  MS ChE.  Responsible for the execution of validation projects, including validation strategy and resource plan, at various sites.  Background in training, organizing forums for best practices, FDA inspections as SME, CAPA, complaint activities, root cause, risk assessments. Led Six Sigma projects in quality, downtime, and warehouse.   $110k      85703
  • Regulatory entry level – MS Regulatory Affairs, BS Pharmacy.  Trained in regulatory affairs for drugs, medical devices, and biologics.  Sound knowledge of the development process, Food, Drug, and Cosmetic Act and related laws, and clinical applications.   $35-40k   85769 
  • Research Engineer – MS Mech & Aerospace Eng.   Biomedical researcher and musculoskeletal expert.  Characterized micro architecture and metabolic activity of bone in determining causes of fatigue and fragility in bone, and evaluated treatments and prevention of osteoporosis.  Developed sub-micron resolution 3D image processing methods.  Developed and implemented novel approach to test FDA approved drug therapies for osteoporosis via clinical trials.  $75k   85767
  • Validation Engineer : contract basis – BSME.  ASQ certified quality engineer and auditor with 12 years experience in quality, manufacturing, and validation in cosmetics, pharmaceutical, and medical device mfg.  Protocol writing and execution for parts washers, packaging equipment, water treatment system, bulk processing (freeze dryers, filter dryers, tanks, automation) and associated components and utilities.      85804 
  • Technical Sales Healthcare Products – BS ChE.   Interface with clinicians and health care facilities to promote advanced wound care products. Promote and implement the adoption of the products through training and applications assistance.  Creative in tapping new markets.   85802
  • Quality Control, ESH, Compliance - MA Chemistry, BS Chemistry.  Specializes in managing and executing multiple safety and pharmaceutical projects across all facets of laboratory support/compliance.  Possess strong capabilities in leading Environmental Health and Safety initiatives.  Highly skilled in use of Lab Ware LIMS, chemistry and chemical engineering.  Provide solutions for quality control labs using outstanding communication and presentation skills, along classroom based training in safety, compliance and SOP.    Fluent in Italian and French.  Six Sigma Red Belt.  Prefers NY, NJ, Conn area.  $70-80k.  85633   
  • Sr Chemist , Laboratory Manager -  BS Chemistry. Hands-on, detail-oriented professional with 20+ years spanning all aspects of laboratory management, QC, chemical research, analysis, synthesis, and testing for top tier pharmaceutical organizations. Expansive knowledge of existing and emerging technologies and equipment, plus extensive background in qualitative & quantitative data analysis, development/validation of analytical test methods and laboratory instrumentation protocols, and USP/International Pharmacopeias methodologies.   $88-120k.   #85596 
  • Analytical Chemist – PhD Analytical Chemistry.  Strong academic background and pharmaceutical experience, including Quality Control and cleaning verification.  SME in HPLC/UPLC chromatographic separations. Developed, validated and optimized analytical methods form Phase 1 through mfg commercializing for APIs, raw materials, process intermediates and finished drug product.  Extensive experience working under cGMP, CFR and ICH guidelines and familiarity with Lean Six Sigma techniques.    #85624 
  • Process Engineer Pharmaceuticals -  MS Biochemistry and Biotechnology Engineering.  Six Sigma Black Belt with 3½ years experience in managing projects to reduce cost and improve quality and efficiency.  Has experience in DMAIC methodology, statistical data analysis, FDA qualification, and validation systems.  Lean mfg. experience, solid dosage.    $70-95k.     # 85619

 

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SP ASSOCIATES, INC.
5950 Fairview Road • Suite 515 • Charlotte, NC 28210
Toll Free: 866.488.6677 • Local: 704.643.7250 • FAX: 704.643.1249