"Search and
Recruitment for BioPharma, Pharma,
Medical Diagnostics and Device Client Companies"
 |
 |
 |
 |
 |
 |
Associate Director: Immunoassay and Automation Methods Development
Analytical Biochemistry Development. #2066
This position will provide technical and tactical leadership for the Immunoassay (ELISA, Gyros, enzymatic etc) and Automation areas within the Biological Assay group in the Department of Analytical Biochemistry. In addition to scientific leadership, the candidate will provide performance management, coaching, and career development to staff members so that their full potentials can be attained, while advancing the scientific reputation of our client company.
Responsibilities:
Identify, evaluate, and optimize new cutting-edge technologies for improving efficiency of in-process, release and characterization testing.
Provide scientific and tactical support to the group that result in the resolution of technical or operational issues.
Mentor and manage a growing staff of approximately 30 scientists including Ph.D., Masters, and Bachelors level scientists through 2 direct reports.
Establish an effective group organizational structure and staff utilizing internal and external resources.
Create presentations for outside scientific meetings and conferences to show companys scientific leadership.
Create, supervise the creation, and review of documents such as: development reports, SOPs, validation protocols/reports, CMC regulatory filings (IND, IMPD, BLA, etc.), and scientific journal publications.
Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards.
Candidate Qualifications:
PhD in Biological or related Sciences.
Minimum of 5-10 yrs of experience in a biopharmaceutical company with relevant experience in immunoassay methods development, optimization, troubleshooting, cGMP testing, and tech transfer.
Experience managing minimum of 10 direct reports is required.
Ability to objectively assess and recommend new scientific technologies that will maximize group efficiency, meet scientific objectives, and promote our client company as a leader in the biotechnology field.
Outstanding written, verbal, and presentation skills.
Excellent data analysis skills and ability to make recommendations that impact the scientific and business goals of the company.
Must have strong experience in the creation, and review of documents such as: development reports, SOPs, validation protocols/reports, CMC regulatory filings (IND, IMPD, BLA, etc.), and scientific journal publications.
Location: US East coast.
Refer a colleague for this position top Apply for Position #2066
|
We are seeking a PhD level biostatistician for the orthopedic research group in one of our client companies. In this position, you will be a key member in providing statistical analysis for the clinical research staff, scientists and investigators, thereby positively affecting those with disabilities and limited mobility.
Responsibilities include data analysis, graphical presentation, and interpretation of statistical techniques.
Candidate Qualifications: Education: PhD in Biostatistics, Applied Statistics or related field. At least 2 years experience in a statistical position. Database design experience. Familiar with descriptive statistics and statistical methods, statistical software, the MS Office suite of products, and presentation software. Critical that this person have excellent verbal and written communication skills. Location: US East coast. Refer a colleague for this position top Apply for Position #2067 |
|
|
Compliance Audit Manager: CFR, ISO, DEA #2073 This position will be responsible for managing the various aspects of the Quality and Management Systems including: CFR and ISO COMPLIANCE, internal audits, complaint handling, corrective and preventive actions, document control, labeling control, complaint handling as well as process and software validation. The position will provide primary liaison to the rest of the company on regulatory matters.
Major Duties and Responsibilities: § Manages and maintains the Divisions quality management system in COMPLIANCE with all relevant standards and regulations and in COMPLIANCE with the policies, guidelines and procedures of Company's International (Corporate COMPLIANCE). § Develops and provides training for all staff relative to the quality system and general regulatory requirements impacting the organization. § Reviews complaint rates and trends on an ongoing basis, initiates investigations and champions corrective actions as indicated. § Develops and provides training to selected, cognizant staff relative to the requirements of complaint handling and the Trackwise Complaint Handling System. § Liaison with Manufacturing, R&D, and Product Service to identify quality issues and develop corrective and preventative action plans. § Oversees the internal AUDIT system. Reviews all findings and corrective/ preventive actions for effectiveness. § Serves as primary contact and system administrator for the QUMAS Document Control System. § Reviews Technical Files to support EU registration.
Candidate Qualifications: § Bachelors degree in business, operations, engineering or related field. § At least 5 years of experience working in a FDA/Medical Device industry. § Experience in a supervisory or managerial role, preferred. § Thorough understanding of FDA Quality System regulations for Class 1, 2 and 3 medical devices, ISO 13485, MDD (93/42/EEC), and ISO 9000. § Proficiency in Lotus Notes, MS Project, and MS Office, including Word and Excel. § Ability to understand and use business planning and COMPLIANCE systems such as BPCS and QUMAS.
Location: US MidWest
Refer a colleague for this position top Apply for Position #2073 |
|
|
Scientist I/II: Infectious Disease Research #2069 Major Duties and Responsibilities: We are seeking experienced MS or PhD level Scientists with expertise in Bacterial Pathogens. This position is with our client's Infectious Disease Research group and the successful candidate will design, develop, and execute in vitro and/or in vivo studies, to devise and characterize biologic therapies directed against Gram-negative and/or Gram-positive bacterial pathogens, primarily Pseudomonas aeruginosa and Staphylococcus aureus. The ideal candidate will be able to work as part of a team dedicated to identifying novel strategies to combat serious bacterial infections and have the ability or potential to lead major projects in the antibacterial therapeutic area.
Position Requirements: Experience: Candidates with industrial background in relevant bacterial systems (Pseudomonas aeruginosa and Staphylococcus aureus) are preferred.
Multiple year relevant laboratory experience is necessary in more than one of the following areas: Substantial experience with bacterial-host cell interactions and immunology with Pseudomonas aeruginosa and Staphylococcus aureus is highly desirable. Experience with in vitro assays including opsonophagocytosis, and bacterial drug susceptibility testing is highly desirable. Experience with relevant antibody-based techniques (e.g., FACS, cell-based ELISAs, opsonophagocytosis) and mechanisms of host innate immunity preferred. Hands on experience and knowledge of bacterial and animal strains required for animal model evaluation of antibacterial biological or chemotherapeutics is also highly desirable. Experience establishing and using automation for the execution of medium to high throughput in vitro studies is highly preferred. Experience with bacterial genetic techniques in Pseudomonas aeruginosa and Staphylococcus aureus including familiarity with gene knockouts, replacement and hyperexpression construct strategies and methods in support of target validation and whole cell screening is preferred. In addition the ideal candidate would be a well-grounded critical thinker who can design and implement in vitro and in vivo (survival, bacteremia, organ burden, focal infection, etc.) studies to assess the anti-bacterial potential of biologics alone or in combination with chemotherapeutic agents.
Educational Requirements: M.S. (10-13 years post degree experience) or PhD (3-7 year post-degree experience). in microbiology, or related discipline.
Location: US East coast.
Refer a colleague for this position top Apply for Position #2069 |
|
|
Associate Scientist I/II: Infectious Disease Research, Gram positive & negative, in vitro & in vivo #2070 We are seeking Associate Scientists with experience establishing and performing in vitro assays on pathogenic bacteria, preferably Pseudomonas aeruginosa, minimally gram negatives. S/He will work within the infectious disease research team to execute in vivo studies to characterize biologic therapies directed against Gram-negative and/or Gram-positive bacterial pathogens, primarily Pseudomonas aeruginosa and Staphylococcus aureus. The ideal candidate will be able to work as part of a team dedicated to identifying novel strategies to combat serious bacterial infections. Candidate Qualifications: Demonstrable and relevant laboratory experience is required in one or more of the following general areas: Experience with animal model evaluation of biological or chemotherapeutics for infectious disease prevention and therapy and work with relevant pathogens is required. Experience with relevant in vitro antibody-based techniques (e.g., FACS, cell-based ELISAs, opsonophagocytosis) and bacterial drug susceptibility testing, is also highly desirable. Experience establishing and using automation for the execution of medium to high throughput in vitro studies is preferred.
Experience in Pseudomonas aeruginosa and Staphylococcus aureus bacterial genetics, including gene knockouts, gene replacements and hyperexpression constructs in support of target validation and whole cell screening is also desirable.
Education: The candidate should have relevant experience (BS, 2-5 or MS, 1-3 years) preferably in an industrial setting in relevant pathogenic bacterial systems.
Location: US East coast. Refer a colleague for this position top Apply for Position #2070 |
|
|
Cell Culture/Virology Manager: Cell Culture/Virology PhD #2072 Our International biotech client has a need for a strong cGMP Manager for their fast growing Contract Manufacturing facility. This facility has achieved a 17% growth over the past 12 mos. We are seeking a hands-on scientific Manager for the day-to-day operations, maintenance and regulatory compliance of a cGMP Cleanroom Facility. S/He will manage the continuous improvement of the facility, assist in technology transfer, process development and scale-up activities and will be responsible for cGMP contract Project Management and troubleshooting of the facility. This person will be the face of the cGMP facility to outside clients so presentation skills are extremely important.
Candidate Qualifications: PhD in Virology preferred, Molecular Biology or Biology, Chem/ Biochem or related degree 1 - 3 yrs of hands-on experience in a Pharma/BioPharma cleanroom facility Mammalian Cell/Tissue culture Good grounding in Virology esp. viral propagation Experience in Wave Bag technology, Bioreactors and/or AKTA purification systems is preferred Experience in (recombinant) Protein Purification is a plus Competent working knowledge of cGMP regulations Project Management skills; good computer skills in the MS suite of products
Location: US East Coast
Refer a colleague for this position top Apply for Position #2072 |
|
|
|
|
|
|
If we
are not currently listing a position of interest to you, however you
would
like us to keep you in mind as future positions become open,
please
click on Candidate, fill out the form then click on "Submit".
All correspondence is held in strict confidence.
Sedona, AZ 86351 * USA
* (928) 203-0074 Office
E-Mail