Direct Hire – Manager, Support Operations (19-00523) – PA – Exton

Description:
The Manager of Support Operations will be responsible for the comprehensive operation of cGMP Buffer/Media production suites, clean/sterile equipment preparation, raw material sampling, and Weigh/Dispense activities in a biopharmaceutical pilot scale/commercial launch facility. The individual will manage day-to-day operation of multiple suites providing various support services for the production of preclinical, clinical phase, and commercial launch Biologics materials including production/staff scheduling, generation/ approval/ close-out of all cGMP related documentation, preparation of assemblies and solutions, and suite change-over ensuring compliance to relevant regulations. The Manager will also be responsible for providing support services for cGMP suite cleaning and spent material removal, maintenance of consumable stocks, and movement of raw materials and solutions within the cGMP production suites. 

Responsibilities: 
1. Manage buffer and media weigh/dispense/production suites, clean/sterile assembly preparation, raw material sampling and dispensing. Drive the design, acquisition and implementation and of new technologies for buffer and media preparation. Assist with the transfer of new buffers and media formulations working with GMP Operations and Development laboratory personnel. Oversight of other areas within the facility may be added at the company’s discretion. 
2. Provide general supervision for cGMP suite cleaning and waste removal, stocking of consumables, and movement of raw materials and solutions within the cGMP suites. 
3. Provide direct supervision, training, and hands-on support of production staff in the operation of equipment to support preclinical, clinical phase, and commercial launch batches of all materials. Coordinate and supervise department change-over activities. Serve as the equipment and suite owner to coordinate routine suite and equipment maintenance, calibration, and validation with appropriate internal departments. 
4. Coordinate the preparation/revision of master batch records, SOPs, and review/close-out all cGMP documents, including equipment and process deviations for each campaign. 
5. Assist in troubleshooting equipment issues and batch/material related deviations. Provide timely reporting, investigation, and resolution of manufacturing process/product deviations, change controls, and commitments. 
6. Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines. 
7. Interact cross-functionally with Upstream and Downstream Operations, Facilities, Quality Assurance, Quality Control, VTE, and other internal and external functions to support successful batch production. 
8. Recruit, train, and develop staff supporting operations. Ensure staff are trained in cGMPs, process specific knowledge, equipment operation, and relevant regulations. 

Education: 
• Minimum of a Bachelors in biological sciences or engineering, business or technical management 

Experience: 
• Minimum of 5-8 years in a multi-discipline cGMP production environment, initiating, scheduling, and managing Biopharmaceutical product manufacturing functions. 
• Knowledgeable in operation of washers, sterilizers, and buffer/media single use solution prep equipment. 
• Knowledgeable in cGMP equipment validation, trouble shooting, and maintenance. 
• Ability to identify, investigate, and solve process, product and equipment problems. 
• Strong working knowledge of US cGMP, EMEA, and JP regulations. 
• Excellent written and communication skills. 
• Excellent interpersonal skills. 
• Team player who can excel in a “hands-on” entrepreneurial environment. 
• Previous supervisory experience. 
• Ability to train and develop subordinate technical staff. 
• Fitness for the use of chemical safety respirators for solution handling required
 
Source: Job Diva – Job Listing

Scientist I (19-00518) – TX – Fort Worth

Duties: Conduct advanced analytical analysis of starting materials, in-process materials, and finished materials following established procedures and protocols. Perform material analysis by utilizing chromatographic method development and execution.
Major Accountabilities:
Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
Use proper scientific tools to accurately analyze and trend data, where applicable.
Clearly and accurately records data and conclusions in laboratory notebook.
Prepares technical documents, including reports and procedures.
Communicates and collaborates routinely with colleagues within the function and sometimes within the sub-team. Functionally communicates with supervisor and mentor. Participate constructively in functional teams and at lab meetings, and offers assistance to co-workers.
General upkeep of laboratory, including equipment/ instrumentation.
Revise and author procedures and technical reports as needed.

Skills:
Quality – No critical audit observations.
Quality – Formal CAPAs and deviations not more than 30 days past due.
Timeliness – On time delivery of data in a suitable format (laboratory notebook, LIMS, technical report).
Throughput – Capable of managing several routine tasks at one time.
Adherence to *** standards and governing procedures and processes, in particular, quality, ethical, health, safety, and HSE standards.

Education: BS degree in Scientific discipline with 3 years of related experience; MS degree in related scientific discipline with <3 years; Hands-on laboratory experience with chromatographic analyses, such as GC, HPLC and UPLC, and Empower software
Source: Job Diva – Job Listing

Chiral Analytical/Purification Support Chemist (19-00517) – MA – Cambridge

Duties:
We are seeking an energetic and enthusiastic chromatographer who demonstrates expertise within chiral analytical and purification processes for Drug Discovery projects.

The candidate’s primary responsibility includes development of chiral and achiral methodologies to purify chemist’s samples and investigational analytical and preparative studies of small molecules to support medicinal chemistry projects. The candidate will be expected to communicate well with medicinal chemists, Analytical Sciences, Mass Spec, NMR spectroscopists and other colleagues, in these efforts.

Skills:
At least 3 years of relevant industry experience and demonstrated success in all aspect of modern chromatography methodologies. You must have a strong understanding of organic chemistry and in-depth experience of chromatographic methods, ideally with expertise within chiral analytical and purification processes SFC and HPLC.

Also expertise in data analysis/interpretation and chromatographic instrumentation, data management, software are essential.

Excellent communication skills and strong interpersonal skills are required.

Education:
A degree in Chemistry or equivalent with at least 3 years relevant experience industry experience.
Source: Job Diva – Job Listing

Instructional Designer IV (19-00516) – CA – South San Francisco

Key Responsibilities:
 

  • Drives customer-centric service delivery, quality production, and optimization for impact and efficiency
  • Manage multiple web and mobile projects (priorities and deliverables) simultaneously
  • Maintains high-quality data and leverage analytics to drive data-driven decisions
  • Manages production agency/vendor management and UAT team to coordinate approval for launch
  • Adheres to processes and standards for campaign management and assess operational metrics in order to prioritize work and develop business-focused recommendations
  • Delivers Operational Excellence by identifying and implementing process improvements, define and enforce the Genentech web standards defined  by the DCX web team that enable great customer experience
  • Uses expertise to influence overall service roadmap and portfolio
  • Tests pilots and drives adoption of new capabilities

 
Skills
 

  • Deep familiarity with service production marketing technology, processes, and tools
  • Digital media knowledge and experience in multichannel/digital marketing preferred
  • Ability to apply data and analysis to make data-driven decisions to optimize web and mobile products in order to improve the Digital Customer Experience
  • Must have hands-on experience with Content Management Systems; Adobe Experience Manager a plus
  • Ability to evaluate web design and content to ensure that it is visually impactful, meets brand guidelines and exhibits all of the best practices for delivering fully responsive web content to the targeted audience
  • Must have hands-on skills with HTML and CSS
  • Strong project management skills to meet goals within constraints of time and budget
  • Excellent attention to detail, communication, organization and problem solving skills to ensure quality and consistency of deliverables
  • Adept at vendor/agency management to maintain healthy partnerships and deliver operational excellence
  • Learning mindset and ability to identify/apply learning to other situations

 
Qualifications
 

  • Bachelor's degree
  • 3-5+/5-8+ years experience working in digital/software marketing, digital production, marketing technology, or marketing operations related functions
  • 3+ years experience in website development and management of content-oriented websites
  • Experience with the digital landscape: web, mobile, online ads, social, apps, etc.
  • Experience with SEO and web analytics; experience with Adobe Analytics a plus
  • Self-motivated, driven individual who is happy working in a fast-paced environment; ability to work well independently or in a team setting
  • Strong sense of responsibility and accountability required
  • Experience in the software, CPG, pharmaceutical or biotech industry preferred

Source: Job Diva – Job Listing

Veterinarian (19-00515) – NJ – East Hanover

Duties: 
Conduct the overall program of veterinary care for Company Laboratory Animal Services including, but not limited to, oversight of quarantine and biosecurity practices, health status and species segregation, health surveillance and control of disease, clinical care of animals, oversight of record keeping, aseptic techniques, surgery pain and distress, anesthesia and analgesia and humane euthanasia.
Serve on the Company Animal Care and Use Committee (IACUC) as Attending Veterinarian (AV), attending bi-monthly meetings of the IACUC and provide professional advice in this capacity.
Provide, as needed, surgical and/or ophthalmological support. 
Conduct weekly scheduled facility rounds in support of clinical care, animal health and well-being at Company. Make recommendations or humane decisions on animal health as necessary.
Inspect, as requested, the vivarium facility and its records, as well as any other lab space used for animal treatment, for compliance with federal and local guidelines and regulations pertaining to animal care (semi-annual facility and program reviews by Code of Federal Regulations Title 9).

Review all Animal Procedures (APs), Standard Operating Procedures (SOPs) and policies pertaining to animal care and use, ensuring conformance with federal regulations and guidelines and make recommendations, as necessary, to ensure regulatory compliance.
As needed, provide assessment of the qualifications and competence of Company staff and animal handling personnel. Provide training, and sign off as deemed necessary for Company principal investigators, in vivo users and animal care staff.
As need, conduct a post-approval monitoring program to ensure compliance with IACUC protocol documents.

Assist with communication regarding backup veterinary care during holidays and weekend, or in the event of your absence or other inability to perform Services as veterinarian. Notify Company of the appropriate contact information regarding the designated veterinary backup.
Provide guidance, on an on-call basis to relevant Company staff on the appropriate handing, immobilization, sedation, anesthesia, analgesia and euthanasia of animals. In addition, should it be necessary, provide oversight of surgery programs and postsurgical care.
Source: Job Diva – Job Listing

SQE Supplier Quality Engineer (19-00514) – CA

 Description: Supplier Quality Engineer with Medical Device company.
Keywords: SQE, supplier quality engineer
Relevant Company Experience: Healthcare, Johnson & Johnson, Client Healthcase, Philips, Siemens Healthineers, Client, Cardinal Health, Stryker, Client, Baxter, Boston, Scientific, Esslor, Danaher, B. Brain, Client Biomet, Fresenius, Alxon, 3M Healthcare, Olympus, Smith & Nephhew, Terumo, Dentsply Sirona, Edwards Lifesciences, Hologic, Intuitive Surgical, Hoya, Sonova Holdings, Getinge, Hill-Rom, Varian Medical Systems
Other Factors: Longer duration projects (1yr+)

Description: Perform manufacturing transfer from US to OUS of existing product line with Medical Device company.
Keywords: Quality Engineer, Validations Engineer, Manufacturing Engineer, Manufacturing Transfer, IQ, OQ, PQ, SWV, TMV

Source: Job Diva – Job Listing

Quality Analyst I (19-00513) – PA – Exton

The QC Analyst I has the responsibility to:
-Perform aseptic sampling Pilot Plant critical utilities and controlled environment
-Perform general laboratory maintenance activities such as cleaning, inventory, and ordering of laboratory supplies.
-Perform sample management such as logging samples into LIMS and performing sample reconciliation
-Perform basic laboratory assays such as viable and non-viable environmental monitoring, pH, and conductivity in compliance with all applicable procedures and regulations
-May perform basic microbial identification testing (eg. Gram stain) with the assistance of more experienced level microbiologist
-Assists with the collection of samples for qualification of critical utilities and operations environment in support of the Pilot Plant

The QC Analyst I will:
-Deliver compliant laboratory samples in support of clinical manufacturing and facility monitoring in accordance with appropriate regulatory, corporate and Client DQA procedures
-Assist with the raw materials program including sample receipt and preparation of shipments for contract test laboratory testing.
-May revise procedures as necessary to support laboratory operations with the assistance of more experienced level microbiologist or manager.
-Performs daily routine microbiological sample collection of critical utilities and environmental monitoring, and sample management within the QC Microbiology Laboratory
-Maintains the laboratory in a compliant manner by performing tasks such as cleaning of laboratory and equipment, taking inventory and ordering laboratory supplies.
-Supports raw material testing through incoming sample management and preparation of contract lab shipments
-Performs basic microbial identification testing such as gram stains

The individual will play an important role in sample collection and support for the routine operations required for microbiological support of the Biologics pilot plant. The QC Analyst I-Microbiology performs basic routine laboratory maintenance such as cleaning, inventory and ordering of laboratory supplies. QC Microbiologist I performs all laboratory procedures under the guidance of a more experienced analysts or manager

Education:
BS or MS in biological or chemical sciences or equivalent

Experience:
-BS in Microbiology, or other relevant scientific discipline.
-A minimum of 0-1 year of working experience in a cGMP Quality Control department in an FDA-regulated industry preferred
-Knowledge of microbiology concepts and aseptic technique used in microbiological testing.
-Ability to perform repetitive tasks while maintaining speed of work and attention to detail.
-Working knowledge of MS Office applications.
-May lift up to 30 lbs.
-May be asked to work occasional weekends during campaigns.
-Hours 7:30am – 4:30pm or 8am – 5pm

MUST HAVES:
– Microbiology background/experience in pharma (preferred) or lab, NOT chemistry
– ENTRY LEVEL position
– Strong attentional to detail
– Experience with sample collection
Source: Job Diva – Job Listing

Laboratory Technician I (19-00512) – MA – Framingham

Summary:
Major responsibilities include routing sampling of cell culture experiments at various scales from shake flasks to bench-top bioreactors, setting up and taking down bioreactors before and after experiments, daily bioreactor sampling and data entry.
This individual will also be part of the lab rotation in executing some routine lab activities.
These activities include stocking, organizing, and inventory of disposal supplies. 
This individual will assists with preparation of small batch quantities (&lt;10L) media and buffer solutions as needed.
Clean and organize laboratories, common equipment, lab areas, and other parts of the building as needed.  
This individual works and communicates well with a team, particularly if they need further clarification in order to proceed with a job task.
This individual is familiar with sterile technique, good laboratory and notebook practices.
This employee must be willing to learn new laboratory techniques.
May involve work with hazardous materials. On the job training will be provided.
 
Skills:

A general knowledge of laboratory procedures, equipment and terminology. 
This individual is expected to be able to perform standard algebraic calculations for lab work such as serial dilutions and concentration calculations for solutions.
Having a basic understanding of dimensional analysis is a plus.
Should be able handle multiple tasks simultaneously.
Able to carry out tasks according to verbal and written instructions.
Demonstrated interpersonal skills and effective communication skills required. 
Demonstrated ability to operate and care for laboratory equipment.
Requires physical demands of lifting up to 30-35 pounds.

Education:
Associate or Bachelor’s degree in Biotechnology, (Bio) Chemical Engineering, Biochemistry or equivalent related fields with 0-2 years of relevant industrial experience
 
Source: Job Diva – Job Listing

Laboratory Analyst I — MTS & Packaging Development (19-00510) – NJ – Ridgefield

Duties:
Primarily responsible for performing all technical laboratory processes including clinical testing related activities as required by schedule and as per manager discretion. Individual will be required to record all data in specified formats and/or maintains a lab notebook detailing day-to-day testing; reporting results of testing activities using electronic, written, oral, or graphical presentation.

Will be responsible for monitoring, ordering and/or receiving delivery of laboratory supplies and equipment, and will be responsible for and/or performing lab and/or facility housekeeping and maintenance. Individual must ensure that corporate, quality, regulatory and safety procedures/requirements are being observed and followed at all times.

PREFERRED QUALIFICATIONS:
Experience in Microsoft Office; Empower data system and lab based data management systems.
Familiarity with USP and global compendia regulations.
Experience troubleshooting of assay and equipment issues.

Education:
Bachelor’s degree in Life Sciences discipline and 0-2 years of experience in CGMP lab environment, or Master’s degree in Life Sciences discipline.
Source: Job Diva – Job Listing

Clinical Trial Coordinator (19-00509) – NJ – Woodcliff Lake

The purpose of this contract is solely for trial master file (TMF) review and reconciliation.

The CTA must have extensive TMF experience – Preferably using the Phlexglobal System which Client uses. Minimum 2 years relevant experience preferred.

What does extensive experience mean?
1. Understand the filing plan and perform logic checks to make recommendations to the study manager to add or remove placeholders as appropriate

2. Document knowledge – They must understand the key documents and not just recognize that there is a document in the placeholder. This also includes expertise in knowing which documents correlate to other documents. Eg. CVs, medical licenses, financial disclosures should match what is written on the 1572, all present, accurate and up to date

3. Global expertise – Understand what is required for country level and site levels in the different countries and do logic checks

4. Study level – Trial level, country level and site level expertise. For the Trial level this includes expertise in knowing which documents are required for each department; Data Management, Statistics, Safety, DSMB, etc.

Client training will be provided:
TMF related SOPs
Training by TMF group
Understanding of which documents are stored outside Phlexglobal
Study Manager will be assigned to support and answer questions
Source: Job Diva – Job Listing

Clinical Trial Coordinator (19-00508) – NJ – Woodcliff Lake

The purpose of this contract is solely for trial master file (TMF) review and reconciliation.

The CTA must have extensive TMF experience – Preferably using the Phlexglobal System which Client uses. Minimum 2 years relevant experience preferred.

What does extensive experience mean?
1. Understand the filing plan and perform logic checks to make recommendations to the study manager to add or remove placeholders as appropriate

2. Document knowledge – They must understand the key documents and not just recognize that there is a document in the placeholder. This also includes expertise in knowing which documents correlate to other documents. Eg. CVs, medical licenses, financial disclosures should match what is written on the 1572, all present, accurate and up to date

3. Global expertise – Understand what is required for country level and site levels in the different countries and do logic checks

4. Study level – Trial level, country level and site level expertise. For the Trial level this includes expertise in knowing which documents are required for each department; Data Management, Statistics, Safety, DSMB, etc.

Client training will be provided:
TMF related SOPs
Training by TMF group
Understanding of which documents are stored outside Phlexglobal
Study Manager will be assigned to support and answer questions
Source: Job Diva – Job Listing

Product Safety Data Coordinator and Coding Associate(Product Safety Coordinator) (19-00506) – NJ – Woodcliff Lake

Job Description:
Receipt and triage of adverse event reports for marketed and investigational products from all sources. Preliminary evaluation of clinical trial, spontaneous (post-marketing), and solicited reports of adverse events, including communication with partners and affiliates when necessary to verify completeness and accuracy.
Case preparation – duplicate searches, initial data entry, and assignment of cases to Specialists. Particular emphasis is placed on determination of seriousness, expectedness, and validity. Prioritizes workload to ensure Company and Regulatory Authority deadlines are met. May include internal and external distribution of information to co-marketing partners, Client affiliate offices, and others as requested.

Requirements:
• Bachelor’s degree required, preferably in a scientific or medical discipline
• Previous experience in data coding and retrieval skills using database technology
• Knowledge of medical terminology
• Prior work experience in Product Safety/Pharmacovigilance preferred
• Precise attention to detail and ability to multi-task
• Good communication skills, both written and verbal
• Ability to work independently, and as part of a team

 
Source: Job Diva – Job Listing

Research Assistant I — : Biologics Res (19-00505) – MA – Framingham

Summary:
The Research Assistant will work in a small team setting to support developability assays for protein therapeutics including monospecific and multispecific antibodies. You will be involved with analytical methods for routine testing and extended characterization of physicochemical attributes of therapeutic proteins.
You will be responsible for analysis of protein purity by SDS-PAGE, HPLC-SEC, HIC and DLS.
You will conduct protein stability assays, by thermal denaturation and accelerated degradation methods.
You will analyze, interpret, document and present data to the team.
You will contribute to group knowledge and expertise through collaboration and idea exchange with a multidisciplinary team.
The individual must be highly motivated, ready to learn new skills and adapt, have meticulous bench-work and record-keeping, and be able to function independently.

Skills:
Experience with standard protein characterization techniques such as SDS-PAGE, HPLC (SEC, HIC) and/or CE-based (CE-SDS, icIEF) methods.
Experience with routine lab equipment and methods, including preparing buffers, measuring pH, UV absorbances, etc.
A strong understanding of protein structure and biophysical chemistry.
Demonstrated ability to analyze, interpret and present data in a clear manner.
Excellent communication and interpersonal skills.

Education:
BA/BS or MS degree in Biochemistry, Biophysics, or a related field with 1-3 years of research experience in protein engineering, protein biochemistry or biophysics is required.
Source: Job Diva – Job Listing

Pharmacoepidemiologist (19-00504) – MA – Cambridge

Responsible for providing pharmacoepidemiology support to marketed and investigational products.
More sprecifically to design and implement pharmacoepidemiological studies and post-authorization safety studies (PASS), conduct epidemiological literature review, prepare pharmacoepidemiological sections of risk management plans, prepare responses to health authorities regarding epidemiological literature or epidemiological studies, conduct benefit-risk analysis.

In depth knowledge of pharmacoepidemiology methods and data sources.
Capability to clearly communicate complex epidemiologic issues to both the scientific community and the general public. Written and verbal communication proficiency in English, including the presentation of data.
Demonstrated ability to formulate investigational plan and capability to work in crisis situations.
Teamwork, excellent interpersonal skills and proven time management skills.
Source: Job Diva – Job Listing

Research Associate II — 6CL124 : Imaging 9000 (19-00503) – MA – Framingham

Duties:
Responsible for the execution and analysis of experiments and analytical procedures. Displays an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigates basic technical problems and performs routine scientific procedures and experiments under general supervision. Plans and prioritizes concurrent experimental procedures. Integrates, complies, and tabulates data and assists supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Works under active supervision. Follows established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy. Contributes to the completion of milestones associated with specific projects. Failure to achieve results or erroneous execution may cause delays in program schedules, and may result in the allocation of additional resources. Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters.
The position is for preclinical imaging research. The candidate will be providing animal imaging expertise for R&D projects. The successful candidate needs to have hands-on MRI and/or PET/CT laboratory experience in preclinical in vivo studies. The candidate will be involved in the application of Client methods and must demonstrate a keen awareness of image acquisition, animal handling, lab skills, image analysis and data visualization to help advance the imaging methods. Clear, concise, and accurate communication skills are a requirement in order to communicate with the various research groups. The candidate is also expected to have excellent writing and presentation skills.

Skills:
Hands-on experience with animal MRI (especially Bruker MRI), etc. and skills for image data analysis/visualization are required. Excellent oral and written communication skills and the ability to collaborate in a team-oriented setting are also required. Must enjoy independent scientific research and being a motivated team-player.
Source: Job Diva – Job Listing