GMP Manufacturing and Process Development Manager

Read PDF

Xintela is a biomedical company working in the field of regenerative medicine with first focus on treatment of osteoarthritis. For more information about the company, see www.xintela.se. We are currently expanding and building our own GMP facility at Medicon Village in Lund for manufacturing of stem cell based advanced therapy medicinal products (ATMPs) for clinical trials. The cleanroom is currently being finalized and the qualification/validation of the facility and equipment, as well as the creation of the quality system, is ongoing.

We have a strong committed team which we now need to expand with a GMP Manufacturing and Process Development Manager. In this position you will be responsible for the manufacturing of mesenchymal stem cells for clinical trials and work in tight collaboration with the different product development functions in the company including R&D, QA and QC. As a member of a dynamic team in a small company you will have the opportunity to participate in both early R&D and in preparations for clinical trials, and you will have a strong influence on the activities performed.

In this role you will be responsible for the management of the cleanroom as well as working hands on with product development and manufacturing. This includes participation in a variety of activities such as maintenance of cleanroom procedures and SOPs; qualification/validation of equipment, manufacturing processes and analytical methods; performance of laboratory experiments; handling of materials and reagents; manufacturing of batches and reporting of data.

Main Responsibilities:

• Managing the cleanroom and cleanroom procedures

• Development and Implementation of the manufacturing processes

• Planning of manufacturing activities and manufacturing timelines.

• Manufacturing mesenchymal stem cells for clinical trials

Preferred Experience and Qualifications:

• BSc or MSc, or similar, in relevant field.

• Experience in pharmaceutical development, preferably within ATMPs or biologics.

• Understanding of the translation from pre-clinical development to clinical phase.

• Experience of cell culture techniques.

• Knowledge of GMP/QMS/SOPs/QC.

• Experience in cleanroom/aseptic techniques.

• Experience in the preparation of documents for regulatory submissions (e.g. IMPD).

• Understanding of flow cytometry (FACS) analysis is advantageous.

• Business level written and spoken English.

• Strong interpersonal and networking skills.

• Strong computerized systems skills.

The person we are looking for should be problem solving, innovative, strategic minded and should thrive in a flexible work environment.

For questions or information regarding the position, please contact Liselotte Theorell (liselotte@xintela.se) or Evy Lundgren-Åkerlund (evy@xintela.se).

Send your application to Sara Baker (sara@xintela.se) as soon as possible but no later than 2 May 2018. Applications will be reviewed continuously.


About Xintela
Xintela develops medical products for regenerative medicine and cancer based on its proprietary marker technology, XINMARK®. Xintela uses the technology to select and assure the quality of mesenchymal stem cells for the treatment of cartilage damage and osteoarthritis. In a study on horses, the company has shown that stem cells are safe to use and that they have a positive effect on the articular cartilage and the underlying bone after an injury. In addition, Xintela has developed an assay XACTTM for the quality control chondrocyte preprations in cell therapy of cartilage. XINMARK® is also used for the development of an antibody-based treatment (Antibody Drug Conjugate, ADC) against glioblastoma, the most common and aggressive form of brain tumors in adults. Positive preclinical results from cell studies and animal model have shown that the antibody has a killing effect on glioblastoma cells and thus has confirmed the concept. Xintela is listed on Nasdaq First North Stockholm since 22 March 2016. Xintela's Certified Adviser at Nasdaq First North is Erik Penser Bank AB, +46 8-463 80 00.

Archive

Below you will find the collected information on Xintela’s press releases, newsletters, diary events, films, media coverage and analyses.

April 17, 2018
Xintela develops unique methods in stem cell therapy for the brain and broadens patent portfolio
March 20, 2018
Xintela prepares for a possible spin-out of its oncology business into a separate company
February 22, 2018
Xintela publishes the Year-end Report for 2017-01-01 - 2017-12-31
December 29, 2017
Xintela licenses human antibody technology for cancer therapy
December 19, 2017
Xintela to collaborate with Japanese CellSeed Inc.
November 13, 2017
Xintela raises 17 million SEK in debt and equity
October 17, 2017
Keld Søndergaard has resigned from the company’s Board of Directors, citing personal reasons.
September 11, 2017
Xintela building own GMP-facility for stem cell production
July 17, 2017
Xintela recruits Liselotte Theorell as Director Product Development and Quality Management
June 22, 2017
Xintela participates in multi-million, government funded initiative to form a cell and gene therapy research center
May 22, 2017
Xintela signs Memorandum of Understanding with the leading European cell therapy company, CO.DON
May 9, 2017
Xintela: Keld Sondergaard nominated as new board member
March 21, 2017
Xintela announces today that Thomas Areschoug has been recruited to the business development team......
February 8, 2017
(In Swedish) Xintela: Insynspersoner och huvudägare avser nyttja teckningsoptioner av serie TO1
January 20, 2017
Xintela reports positive preclinical results in cancer project
January 4, 2017
Xintela´s stem cells show positive treatment effects on cartilage damage in horse study
December 22, 2016
Xintela reports positive results from completed horse study
September 12, 2016
Xintela announces that Rickard Mosell has been recruited as Head of Business Development from October 1, 2016.
August 22, 2016
Xintela today announces that it has settled a dispute and will receive 1,500,000 Swedish Crowns in compensation.
June 23, 2016
Xintela announces that Christer Betsholtz has been engaged as a scientific and strategic advisor
June 1, 2016
Xintela strengthens its organisation wih the appointment of Caroline Ehrencrona as Director Clincial Development and Regulatory Affairs
April 25, 2016
Xintela initiates a study on the treatment of cartilage damage in horses in the USA.
March 16, 2016
Xintela's press releases are currently only published in Swedish. Please contact us if you have further questions.
April 10, 2018
Xintela is seeking a GMP Manufacturing and Process Development Manager, responsible for the manufacturing of stem cells for clinical trials
March 27, 2018
Large-scale stem cell production paves the way for GMP-certified production
January 5, 2018
Pre-Christmas breakthrough promises an exciting 2018
September 28, 2017
‍Strategic decisions that builds significant value
July 19, 2017
Focusing on Stem Cell Production and Preparations for Clinical Trials
May 16, 2017
On the 21st March 2017, Xintela reported that it was strengthening its Business Development team...
April 5, 2017
A word from the CEO
April 5, 2017
The subscription period for shares supported by warrants has started
December 29, 2016
A Year of Significant Progress
December 14, 2016
Glioblastoma—Xintela's Focus in the Cancer Arena
November 8, 2016
Starting the Autumn with an increased focus on Xintela’s commercial development
October 19, 2016
Since our listing in the Spring, the company has developed in a very positive way and we are on track with the milestones we have set.
August 11, 2016
Confidence in the future with a strong organisation
August 11, 2016
Welcome to Xintela's newsletter
April 9, 2018
9 - 12 April: ICRS Conference, Macau, China
The ICRS Conference will be held between 9 and 12 April. It is arranged every 18 months, and will this year take place in Macau, China
February 9, 2017

Dr. Marcus Keep comments on Xintelas glioblastoma project.

January 31, 2017

Xintelas Chairman of the board and strategic advisor Greg Batcheller, tells us more about Xintelas potential and prospects.

January 30, 2017

Dr. Lisa Fortier at Cornell University, New York is interviewed by BioStock about Xintelas positive results in horse study.

December 28, 2016

In the following video interview, Karin explains her role at Xintela and what she considers to be Xintela’s primary strengths.

December 13, 2016

See the interview with Claes Post, member of the board in Xintela. The interview is in swedish with english subtitles.

March 24, 2016

See the interview with Sven Kili, member of the board in Xintela. The interview is in English (introduction is in Swedish).

March 22, 2016

See an interview with Xintela's CEO Evy Lundgren-Åkerlund, after the listing ceremony at Nasdaq First North.

March 16, 2016

Investor presentation from Lund - Jan 27

March 15, 2016

Interview with Xintelas CEO

June 22, 2017
Xintela covered in GEN regarding its participation in multi-million, government funded initiative to form a...
March 2, 2017
Xintela covered in Horsetalk.co.nz regarding that its stem cells are safe for use in horses
March 23, 2016
(Article in Swedish) Xintela tar behandling av ledskador och cancer till First North.
March 23, 2016
(Article in Swedish) Grundare av Xintela ser notering som viktig milstolpe
March 23, 2016
(Article in Swedish) Xintela covered in Life Science Sweden
February 24, 2016
(Article in Swedish) Rapidus: Xintela på väg till First North
April 12, 2018
Read the full analysis here
Top