Frontida is actively recruiting innovative and caring professionals. Here, you can help develop and build a culture of caring, accountability and continuous improvement (both individually and corporately). Frontida careers extend from pharmaceutical formulation scientists to quality assurance specialists, information technology to regulatory compliance professionals, and manufacturing to mechanical specialists. Join a powerful, results-oriented team.

Job Summary

Responsible for the documentation, installation, calibration/verification/qualification, preventive maintenance, and repair of a wide variety of scientific instruments used at AR&D, Frontida Biopharm, Inc., including but not limited to: HPLC, UPLC, GC, UV/Vis, FTIR, dissolution, particle size analyzers, etc.

Responsibilities

  • Calibrates/verifies/qualifies and performs preventative maintenance on laboratory equipment which include, but are not limited to, HPLC, UPLC, UV/Vis, GC, dissolution, FTIR, particle size analyzers, etc.
  • Inspects, evaluates, troubleshoots, and repairs laboratory equipment when problems arise.
  • Documents, reviews, and audits calibration/maintenance/repair activities of laboratory equipment.
  • Maintains calibration/maintenance schedules to keep the Calibration Program up-to-date.
  • Completes all work in a safe and efficient manner in accordance with cGMP and GLP requirements.
  • Maintains and archives calibration/maintenance/service records in Blue Mountain RAM.
  • Assists in the installation, operation, and performance qualification (IQ/OQ/PQ) of laboratory instruments.
  • Installs/re-installs, disassembles, cleans and makes necessary modifications to various instruments.
  • Records and reports out-of-tolerance results and any other instrument-related issues to the manager and performs corrective actions as directed.
  • Arranges for vendor service when necessary.
  • Maintains inventory and researches options on prices and availability of parts.
  • Works closely with users and external groups to help operate instrumentation and develop techniques that will meet the needs of the user community.
  • Participates in writing SOPs, protocols, and instrument validation plans.
  • Aids in laboratory investigations due to instrument-related issues when needed.
  • Explores ways that maximize efficiency at lower costs.
  • Must participate and successfully complete all company training, as required.
  • Performs other duties as assigned.

Knowledge and Skills

Bachelor’s degree in Chemistry or Associate’s degree (A. A.); one to two years related experience and/or training; or equivalent combination of education and experience. Calibration/ Maintenance/Service certifications in lab equipment are preferred. Knowledge/skill/experience in the operation of various laboratory instruments is required. 1-2 years of HPLC, UPLC, GC, Dissolution, UV/Vis, FTIR, and/or Particle Size Analyzer calibration, maintenance, and/or repair experience is preferred. Previous experience in the pharmaceutical industry highly desirable. Must have good communication and technical writing skills. Proficiency in Microsoft Word, Excel, and Outlook and the ability to learn other software applications, as required. Experience with Blue Mountain RAM is preferred.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Review, plan, evaluate, develop, install, expand, administer, maintain, test and/or troubleshoot network systems and applications such LANs, WANs, Internet, Intranet, and other data communications systems. Manage servers, systems, backups and Active Directory. Provide documentation, project tracking, and management reporting. Provide tactical and strategic input on overall network planning and related projects.

 

 

 

Responsibilities

Maintain a wide array of infrastructure components and technologies, including switches, firewalls, SD-WANs, VPNs, routers, wireless technologies, VoIP phone systems, etc.  Ensure optimum performance of applications and networks.

Be an agent of change to update and upgrade systems where needed through thoughtful planning and implementation in a controlled manner.

Manage, monitor, upgrade VMware infrastructure including iSCSI SANs.

Manage and monitor server backups, utilizing Backup Exec.

Maintain Microsoft Exchange mail server environment.

Maintain and monitor security layers to ensure safe operation of our computing resources.

Build, install, and implement and maintain servers running Windows 2003, 2008 and 2012.

Maintain integrity of systems documentation.

Work with contractors, vendors, business partners, and end users.

Maintain Active Directory, accounts, group policies, and NTFS permissions.

Must participate and successfully complete all training as required by the company.

Perform other duties as assigned.

Qualifications

Associates degree or technical school certification in related field (Bachelor’s degree a plus) and 3+ years of related experience with Microsoft Windows Operating Systems and related networks, Active Directory Services, Local and Remote Administrative Tools or equivalent combination of education and experience.

Knowledge and Skills

Experience with Cisco network equipment, Backup technologies and software, VMware, Citrix, Microsoft SQL, SharePoint, Exchange Server, Network Monitoring Tools, VPNs, and SANs preferred. Microsoft, Cisco, VMware, Fortinet certifications are a plus. Proficient in the use of Microsoft Office, Project, Visio, and other applications as applicable, plus the ability to learn company-used applications as required.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Oversees, the development, implementation, compliance, reporting and monitoring of the Company’s environmental, health and safety (EHS) programs. Overall responsibility to ensure Company standards & regulatory requirements are met with respect to the safe operation of the company facilities.

 

Responsibilities

  • Ensures compliance with applicable federal, state, and local regulations as well as company policies.
  • Compiles and submits all required reports to local, state and federal authorities. Compiles and maintains accurate recordkeeping for all regulatory agencies including OSHA, EPA, DEP, DOT, etc.
  • Responsible to see that lost time and OSHA recordable safety goals are met. Oversees and maintains day-to-day safety programs at the company’s facilities.
  • Coordinates the investigation of incidents as necessary, reviews, approves incident reports.
  • Evaluates potential workplace hazards and ensures that ongoing programs/remedies are implemented.
  • Promotes the safety program and strongly influences employees and management teams throughout the organization, by developing, implementing and maintaining general company safety policies and procedures to ensure regulatory compliance and promotion of company objectives.
  • Inspects (audits) organization facilities to detect existing or potential safety and health hazards, and recommends and implements corrective or preventative measures, and follows up to ensure measures have been implemented.
  • Advise management on health and safety issues and recommend ways to improve the safety of our operations. Follows up with departmental management to ensure that recommendations are implemented as required.
  • Develops training policies, programs, and schedules, selects or develops teaching aids such as training handbooks, demonstration models, multimedia visual aids, computer tutorials, and reference works and conducts training sessions.
  • Communicate Safety & Health requirements and assist departments in implementing responsive programs, promote and encourage the safe utilization of equipment and facilities.
  • Chairs and directs the safety committee.
  • Represents the company to governmental inspectors, insurance companies, and contractors as appropriate.
  • Provides safety assessments for proposed research products. In the absence of published OEL or TWA, sets limits based on scientifically-defensible techniques and data.
  • Maintains and monitors the following and other programs as necessary: MSDS Database, fire extinguishers, hazardous and non-hazardous waste handling, respirator training, safety glasses, etc.
  • Provides and administers training for fork truck, confined space, violence in the work place, blood borne pathogen, fire extinguisher, HAZCOM, PSM, Lock-out/tag out, confined space, CPR, respirator & respirator fit test, hot work, incident/accident, DOT, IATA, HAZWOPPER, etc. This includes new employee  and contractor safety orientation and training.
  • Ensures proper safety apparel, equipment and services are provided, i.e. Safety Shoe and Glasses programs, etc.
  • Provides or arranges industrial hygiene services where appropriate.
  • Coordinates workers’ compensation program, including working with the employee, insurance carrier and medical providers regarding appointments, lost-time, restrictions, etc. also maintains safety files and records
  • Other duties may be assigned.

Qualifications

• Bachelor’s Degree in Chemical Engineering, Safety Engineering, EH&S Management or related field. Professional certification is a plus.
• Five plus years of experience, in a manufacturing environment required, Chemical or Pharmaceutical industries a plus. Previous experience with pharmaceutical solid dosage manufacturing and managing a staff in a cGMP regulated environment.
• Must have thorough and demonstrated knowledge and experience with federal, state and local Safety & Health regulations, including DOT, OSHA, etc.

Knowledge and Skills

  • Experience in development, organization and implementation of facility-wide, safety programs.
  • Demonstrated ability to recognize, evaluate, and recommend controls for workplace hazards.
  • Demonstrated ability to determine training needs, organize and/or conduct training. Excellent written and oral communication skills.
  • Computer literate and proficient with Microsoft office suite and applicable applications related to perform the Safety Coordinator function.
  • Strong communication skill.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.

 

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Director, Compliance and Quality Systems will have the responsibility for managing and leading functions that include but are not limited to investigations, training, internal auditing, quality oversight of validation (process and computer), metrics and quality council primarily for Frontida PA and for Frontida Aurora where processes are shared across sites.

Responsibilities

Responsible for leading the compliance processes and quality systems including investigations, training, internal auditing, quality oversight of validation (process and computer), and metrics reporting. Ensure these processes are designed and executed according to cGMP, company SOPs and applicable regulations.

 

  • Collect metrics across the company for trending of quality performance, identification of trends and improvement opportunities
  • Lead the quality council management review meetings by presenting metrics, quality initiatives and driving quality improvement across the organization
  • Manage direct reports and team, drive a high performing organization, develop personnel for current and future roles within Frontida
  • Provide Quality support for electronic system integration
  • Collaborate across sites to develop common processes and procedures where applicable
  • Drive continuous improvement of quality systems to proactively mitigate current and future risks to support business needs

Knowledge and Skills

  • Bachelor’s degree in in a related discipline with 10-15 years of experience in pharmaceutical quality with broad knowledge of GMPs, solid and oral dosage forms, manufacturing and auditing, required
  • Experience leading teams to improved performance demonstrated through metrics
  • Knowledgeable of cGMPs and regulations pertaining to quality system requirements for oral dosage forms, preferred
  • Experience with quality systems, investigation writing, CAPA, preferred
  • Experienced in conducting internal audits, and preparing for and hosting agency inspections and audits, preferred.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Responsible for the documentation, installation, calibration/verification/qualification, preventive maintenance, and repair of a wide variety of scientific instruments used at Frontida BioPharm, including but not limited to: HPLC, UPLC, GC, UV/Vis, FTIR, dissolution, particle size analyzers, etc.

Responsibilities

  • Calibrates/verifies/qualifies and performs preventative maintenance on laboratory equipment which include, but is not limited to, HPLC, UPLC, UV/Vis, GC, dissolution, FTIR, particle size analyzers, etc.
  • Inspects, evaluates, troubleshoots, and repairs laboratory equipment when problems arise.
  • Documents, reviews, and audits calibration/maintenance/repair activities of laboratory equipment.
  • Maintains calibration/maintenance schedules to keep the Calibration Program up-to-date through the Computerized Maintenance Management System (Blue Mountain Regulatory Asset Manager).
  • Completes all work in a safe and efficient manner in accordance with cGMP and GLP requirements.
  • Maintains and archives calibration/maintenance/service records.
  • Assists in the installation, operation, and performance qualification (IQ/OQ/PQ) of laboratory instruments.
  • Installs/re-installs, disassembles, cleans and makes necessary modifications to various instruments.
  • Records and reports out-of-tolerance results and any other instrument-related issues to the manager and performs corrective actions as directed.
  • Arranges for vendor service when necessary.
  • Maintains inventory and researches options on prices and availability of parts.
  • Works closely with users and external groups to help operate and develop techniques that will meet the needs of the user community.
  • Participates in writing SOPs, protocols, and instrument validation plans.
  • Aids in laboratory investigations due to instrument-related issues when needed.
  • Explores ways that maximize efficiency at lower costs.
  • Must participate and successfully complete all company training, as required.
  • Performs other duties as assigned.

Knowledge and Skills

Associate’s degree (A. A.) or equivalent from technical school; two to four years related experience and/or training; or equivalent combination of education and experience. Bachelor’s degree in Engineering or Chemistry is preferred. Calibration/Maintenance/Service certifications in lab equipment are required. Extensive Calibration/Maintenance/Repair experience on various lab instruments required. Minimum 2 – 4 years experience of HPLC, UPLC, GC, Dissolution, UV/Vis, FTIR and/or Particle Size Analyzer calibration, maintenance, and/or repair experience is preferred. Previous experience in the pharmaceutical industry highly desirable. Must have good communication and technical writing skills. Proficiency in Microsoft Word, Excel, and Outlook and the ability to learn other software applications, as required.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

For a contract manufacturing organization (Frontida BioPharm, Inc. – Philadelphia, PA): perform method development, verification and validation for drug products and raw materials using various analytical procedures and dissolution techniques; perform reverse engineering for generic products; optimize procedures of analytical methods; investigate abnormal results; operate and troubleshoot GC, HPLC, UPLC, UV/Vis and FT-IR.

 

Work Location: Philadelphia, PA.

Hours: 40 per week – Monday through Friday

To apply online.

Qualifications

Requirements:

  1. Master of Science or foreign equivalent degree in Chemistry, Analytical Chemistry or a related field.
  2. 2 years experience in job offered or 2 years experience as a Research Scientist in the pharmaceutical industry.  This required experience must include 1 year experience in generic products development (suspension, injectable, tablets, capsules), small scale per cGMP procedures and manufacturing processes optimization, and 1 year experience in reverse engineering for products and analytical method development/validation using HPLC, LC-MS/MS, UPLC, GC, GC-MS, fluorescence, XRD and particle size analytical techniques, including Mastersizer and Zeta Potential.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The QA Associate will be responsible for supporting compliance activities for GxP operations. The QA Associate will be responsible for a diverse and challenging set of activities related to setting and maintaining quality standards aligned with FDA cGMP regulations.

 

Work location: Aurora, IL (relocation assistance is not provided)

Responsibilities

Review and approve Deviations, CAPAs, investigations, complaints

Auditing Responsibilities

  • Audit all areas of production for adherence to cGMPs.
  • Perform and participate in internal audits and facility inspections.
  • Support and participate in regulatory audit preparedness and during inspections by regulatory agencies.

Calibrate QA and/or production equipment.

Support QA Associate III in executing cleaning validation, purified water and environmental monitoring programs

Knowledge and Skills

Requires a Bachelor’s degree in any life science, preferably in Chemistry and/or Biology. The various QA Associate II levels require the following experience in a regulated environment in Quality Assurance, Quality Control, Compliance, or Manufacturing with 2 to 4 years’ experience.

The candidate must have training in cGMPs and/or cGxPs and relevant regulatory guidelines. Must be familiar with relevant regulations; formal training and/or advanced courses are preferred. Must have excellent interpersonal skills and the ability to communicate company policies and procedures clearly.

Must have strong organizational and record keeping skills, and the ability to handle multiple projects. Ability to work independently in fast-paced environment with little supervision. Ability to adapt to contact change and work effectively in abstract environment. Candidate must be motivated and detail-oriented. Proficient at mid-level in Microsoft Office applications (Word, Excel, Outlook), data management systems and business related application packages highly desired, plus the ability to learn company used applications.

 

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The GMP Training System Specialist is responsible for managing the administrative functions of the training system for the Philadelphia locations.  This includes managing job codes, exams, on-the-job training (OJT) documentation and increasing the use of the LMS system functionality to support the site operations and compliance.

Responsibilities

  • Supporting the conduct of effective new employee orientation sessions in a timely manner
  • Process training related tasks and documents through applicable EQMS systems in a timely manner
  • Communicate to job code owners, SOP authors and other key stakeholders when tasks are required of them such as exam writing, review and approval, job code evaluation and task initiation. Drive timely completion by stakeholders to support procedure approval timelines
  • Write or revise exams for new and revised procedures in a timely manner
  • Support authors of SOPs in writing and revising exams
  • Manage Job Code organization and structure to ensure employees are trained appropriately, job codes are organized to support the departments and OJT is reflected in the EQMS where possible
  • Generate reports of pending and overdue training including monthly metrics as requested
  • Assist departments who require On-the-Job (OJT) training to manage the structure and documentation of such training as applicable, e.g., lab modules, manufacturing OJT
  • Other assigned administrative tasks as required in keeping the company compliant with cGMP, industry standards and regulations (e.g., organizing and filing paper-based training records, managing electronic copies of training records on shared drives and in the LMS, etc.)

Qualifications

  • Bachelor degree in education or relevant field with 1-2 years in training or a bachelor degree in a life science with 2-5 years in training
  • Pharmaceutical experience is preferred
  • Strong communication skills
  • Experience in using and managing an electronic learning management system
  • Strong writing skills and record keeping ability for reports and training manuals
  • Good computer and database skills
  • Works well across all departments and functions

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Account Executive is responsible for proactively identifying and evaluating business opportunities that will effectively support the company’s revenue and profit goals.  The position requires knowledge of the brand and generic pharmaceutical marketplace and a successful track record in business development or sales.  The successful candidate must have demonstrated success in identifying market trends and ideas for growing revenue. The successful candidate will join an experienced and sophisticated business development team who compete aggressively in the market while maintaining a collaborative internal culture.  This role is best suited to those who thrive on using their existing relationships to develop creative solutions to build a sustainable revenue stream and are able to propose market segments that will be complementary to the current base business.  The position may require travel at least 30% of the time.

Responsibilities

  • Primarily responsible for driving sales growth with regional and national accounts for new product development, clinical and commercial supply
  • Financial accountability for the achievement of new products revenue, deals signed and delivering pipeline & sales funnel targets.
  • Identifying new clients, initiate contact and close opportunities
  • Prepare, present, negotiate technical pricing proposal for product development, clinical and commercial supply, in coordination with Senior Management, R&D, Contract Management, Legal
  • Conduct technical feasibility of potential new business project, and follow up with missing pertinent data for quotation.
  • Must be prepared to present quotation analysis to all levels of the organization
  • Manage the day-to-day requirements of the business relationship including pricing, contracts, forecasting, periodic business review, and additional items as necessary
  • Participate in internal process teams, conferences, trade shows, marketing campaigns, and professional associations as required.
  • Exceptional client service and account management by managing the day-to-day client activities across a variety of work streams and accounts
  • Represent the company in a professional manner at industry meetings while promoting the brand and generic business. This will include presenting product features and benefits to a targeted trade class of customers

Qualifications

  • Bachelor’s degree coupled with 5+ years of Sales Management experience in the generic or branded pharmaceutical marketplace. MBA Degree is preferred.
  • Established relationships with R&D and Commercial phase Rx pharmaceutical companies
  • Must have past experience developing and executing against customer strategies
  • Must be able to work autonomously and demonstrate superior leadership disposition (poise, business acumen, results orientation and good judgment.
  • Blend of sales and marketing background preferred
  • Strong computer skills, including Microsoft Word, Excel, and PowerPoint.
  • Ability to work effectively in an entrepreneurial environment
  • Balanced work style allowing for equal success whether working independently or collaborating with the team
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.